Catheter, Percutaneous

FDA product code DQY · 850 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1250
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-01-25 – 2026-09-18

DQY 2026-09-18

CrossFAST Integrated Microcatheter Advanced Delivery System

Applicant Vantis Vascular, Inc.

K number K262817

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DQY 2026-08-14

NHanceIT

Applicant IMDS Operation B.V.

K number K260559

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DQY 2026-08-12

APRO 35 Swift Catheter

Applicant Alembic, LLC

K number K262392

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DQY 2026-07-29

SSPC NXT Delivery Catheter

Applicant CenterPoint Systems, LLC

K number K262240

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DQY 2026-07-29

CPS Locator 3D Plus Delivery Catheter

Applicant CenterPoint Systems, LLC

K number K261766

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DQY 2026-07-02

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

Applicant Abbott

K number K261825

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DQY 2026-06-17

Amplatzer TorqVue Exchange System

Applicant Abbott Medical

K number K261631

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DQY 2026-06-05

Perfect-O Ostial Positioning Catheter

Applicant Balosmark, Inc.

K number K260289

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DQY 2026-04-24

Amplatzer TorqVue Delivery System

Applicant Abbott

K number K260993

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DQY 2026-04-10

Teleport Glide Microcatheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K number K253361

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DQY 2026-03-13

Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

Applicant ABBOTT MEDICAL

K number K260499

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DQY 2025-12-19

C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)

Applicant Medtronic, Inc.

K number K253409

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DQY 2025-12-17

Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)

Applicant ABBOTT MEDICAL

K number K252417

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DQY 2025-10-29

Telescope Guide Extension Catheter

Applicant Medtronic, Ireland

K number K252390

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DQY 2025-08-22

CoraForce Microcatheter, CoraFlex Microcatheter

Applicant Reflow Medical, Inc.

K number K251277

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DQY 2025-08-22

CPS Locator 3D Delivery Catheter

Applicant Centerpoint Systems

K number K250147

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DQY 2025-06-29

Primum Hydrophilic Guiding Catheter

Applicant Pendracare

K number K250972

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DQY 2025-06-27

CPS Locator 3D Plus Delivery Catheter

Applicant CenterPoint Systems, LLC

K number K250828

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DQY 2025-06-25

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

Applicant Strait Access Technologies Holdings

K number K243184

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DQY 2025-06-18

FlexiGo 3D Delivery Catheter

Applicant CenterPoint Systems, LLC

K number K250492

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DQY 2025-06-17

Dorado™ PTA Balloon Dilatation Catheter

Applicant Bard Peripheral Vascular, Inc.

K number K250219

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DQY 2025-06-02

GORE® Tri-Lobe Balloon Catheter

Applicant W. L. Gore & Associates, Inc.

K number K250410

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DQY 2025-05-02

Shockwave CS Guide Catheter

Applicant Shockwave Medical, Inc.

K number K243757

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DQY 2025-05-01

APRO 45 Catheter

Applicant Alembic, LLC

K number K251014

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DQY 2025-04-29

APRO 55 Intermediate Catheter

Applicant Alembic, LLC

K number K250962

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DQY 2025-04-25

Amulet™ Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K number K250426

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DQY 2025-04-17

FlowGuide (FG60F); GuidionShort (GS60F)

Applicant Imds Operations B.V.

K number K242337

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DQY 2025-04-04

LiquID .051 LP Guide Catheter Extension

Applicant Seigla Medical, Inc.

K number K243691

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DQY 2025-03-27

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

Applicant Medtronic, Inc.

K number K250558

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DQY 2025-02-28

Seclusion Catheter

Applicant Basis Medical

K number K243436

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DQY 2025-01-15

Ventrax™ Delivery System

Applicant Merit Medical Systems, Inc.

K number K242873

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DQY 2025-01-07

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K number K242588

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DQY 2024-12-31

MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)

Applicant ABBOTT MEDICAL

K number K243224

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DQY 2024-12-20

SENDERO MAX Delivery Catheter

Applicant Okami Medical, Inc.

K number K242644

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DQY 2024-12-19

Shadow Catheter

Applicant Simpson Interventions, Inc.

K number K240885

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DQY 2024-12-04

SSPC NXT Delivery Catheter

Applicant CenterPoint Systems, LLC

K number K243180

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DQY 2024-09-30

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)

Applicant Vantis Vascular, Inc.

K number K242276

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DQY 2024-09-12

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)

Applicant Biotronik, Inc.

K number K240787

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DQY 2024-09-03

ShapeIT (SI014135)

Applicant Imds Operations B.V.

K number K241611

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DQY 2024-08-26

TriClip Steerable Guide Catheter

Applicant ABBOTT MEDICAL

K number K241538

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DQY 2024-06-28

Cordis BRITECROSS Support Catheter

Applicant Cordis US Corp

K number K233637

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DQY 2024-06-25

ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3

Applicant Asahi Intecc Co., Ltd.

K number K241158

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DQY 2024-05-28

React 71 Catheter

Applicant Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

K number K241177

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DQY 2024-03-15

APRO 55 Catheter

Applicant Alembic, LLC

K number K234115

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DQY 2024-03-08

SENDERO Microcatheter

Applicant Okami Medical, Inc.

K number K240384

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DQY 2024-02-08

SINC Support Catheter

Applicant Reflow Medical, Inc.

K number K233350

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DQY 2024-02-01

WATCHMAN TruSteer Access System (M635TU90050)

Applicant Boston Scientific Corporation

K number K240018

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DQY 2024-01-07

Teleport XT Microcatheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K number K231608

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DQY 2023-12-27

TriSalus TriGuideTM Guiding Catheter

Applicant Trisalus Life Sciences

K number K233858

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DQY 2023-11-17

SENDERO Microcatheter

Applicant Okami Medical, Inc.

K number K231600

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DQY 2023-10-31

091 Balloon Guide Catheter

Applicant Eosolutions, Corp.

K number K231629

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DQY 2023-10-13

Paragon 8F Balloon Guide Catheter

Applicant Wallaby Medical

K number K232437

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DQY 2023-09-29

Amulet™ Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K number K232690

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DQY 2023-09-29

Microcatheter

Applicant Surmodics,Inc.

K number K232647

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DQY 2023-08-30

Ventrax™ Delivery System (VTR851)

Applicant Merit Medical Systems, Inc.

K number K231246

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DQY 2023-08-22

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter

Applicant Medtronic Vascular

K number K232190

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DQY 2023-08-08

Rubicon™ Control Support Catheter (H749394323506A1)

Applicant Boston Scientific Corporation

K number K223633

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DQY 2023-07-27

R2P Navicross

Applicant Terumo Medical Corporation

K number K231044

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DQY 2023-07-13

Micro Rx

Applicant Imds Operations B.V.

K number K223728

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DQY 2023-06-30

5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter

Applicant Medtronic Vascular

K number K230156

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DQY 2023-06-02

CPS Direct™ Universal slittable outer guide catheter (DS2C029)

Applicant ABBOTT MEDICAL

K number K231311

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DQY 2023-05-25

Stingray LP Catheter

Applicant Boston Scientific

K number K231176

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DQY 2023-04-06

RayFlow

Applicant Hexacath

K number K222023

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DQY 2023-03-09

CPS Locator 3D Delivery Catheter

Applicant CenterPoint Systems, LLC

K number K230363

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DQY 2023-03-02

6F Wallaby Long Sheath

Applicant Wallaby Medical, Inc.

K number K222603

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DQY 2023-01-10

ISAAC Neurovascular Navigation Catheter

Applicant MicroVention, Inc.

K number K222115

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DQY 2022-11-08

SelectSite C304 Deflectable Catheter System, C315 Delivery System

Applicant Medtronic

K number K223178

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DQY 2022-11-07

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

Applicant Medtronic

K number K222873

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DQY 2022-10-20

Houdini Cross Support Catheter

Applicant Cruzar Medsystems, Inc.

K number K213466

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DQY 2022-10-14

Sublime Microcatheter

Applicant Surmodics,Inc.

K number K221886

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DQY 2022-09-12

SOFIA 88 Catheter

Applicant MicroVention, Inc.

K number K214024

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DQY 2022-08-18

GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)

Applicant Vascular Solutions, LLC

K number K220647

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DQY 2022-07-29

091 Balloon Guide Catheter

Applicant Inneuroco, Inc.

K number K220331

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DQY 2022-07-19

Selectra Lead Implantation System

Applicant Biotronik, Inc.

K number K222037

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DQY 2022-07-11

Artix Ballon Guiding Sheath

Applicant Inari Medical

K number K221846

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DQY 2022-06-30

CPS AIM Universal II Slittable Inner Catheter

Applicant ABBOTT MEDICAL

K number K221750

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DQY 2022-06-02

Boss Crossing Support Catheter

Applicant Marvao Medical Devices, Ltd.

K number K220632

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DQY 2022-05-05

Spartan SC 069

Applicant Spartan Micro, Inc.

K number K220716

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DQY 2022-05-05

LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension

Applicant Seigla Medical, Inc.

K number K220691

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DQY 2022-05-04

Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter

Applicant C.R. Bard, Inc.

K number K212588

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DQY 2022-04-11

XO CROSS CORONARY Support Catheter

Applicant Transit Scientific, LLC

K number K214107

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DQY 2022-03-09

Amplatzer Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K number K220340

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DQY 2022-02-09

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter

Applicant Vascular Solutions, LLC

K number K212211

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DQY 2022-01-28

QuikPass Catheter

Applicant Traverse Vascular, Inc.

K number K214106

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DQY 2021-11-24

Guiding Catheter

Applicant CenterPoint Systems, LLC

K number K210009

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DQY 2021-10-21

XO Cross Support Catheter

Applicant Transit Scientific, LLC

K number K210322

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DQY 2021-09-27

Amplatzer Talisman Delivery Sheath

Applicant ABBOTT MEDICAL

K number K212738

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DQY 2021-09-27

Amplatzer Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K number K212026

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DQY 2021-09-24

ViperCross Support Catheters

Applicant Cardiovascular Systems, Inc.

K number K212725

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DQY 2021-08-26

ViperCross Support Catheters

Applicant Cardiovascular Systems, Inc.

K number K211240

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DQY 2021-08-13

WATCHMAN FXD Curve Access System

Applicant Boston Scientific Corporation

K number K212228

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DQY 2021-07-27

Rist 071 Radial Access Guide Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K number K211990

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DQY 2021-07-15

ReCross

Applicant Imds Operations B.V.

K number K210431

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DQY 2021-07-07

Arterial Catheter

Applicant Haolang Medical USA Corporation

K number K201726

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DQY 2021-05-28

coraCross

Applicant Reflow Medical

K number K210188

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DQY 2021-05-26

ViperCath XC Peripheral Exchange Catheter

Applicant Cardiovascular Systems, Inc.

K number K211251

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DQY 2021-04-30

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter

Applicant Vascular Solutions, LLC

K number K210647

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DQY 2021-04-28

Plato 17 Microcatheter

Applicant Scientia Vascular, LLC

K number K210601

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DQY 2021-03-31

Guidion

Applicant Imds Operations B.V.

K number K210110

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DQY 2021-03-03

FineCross M3

Applicant Ashitaka Factory of Terumo Corporation

K number K203521

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