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 2017-02-01

Twin-Pass Torque

Applicant Vascular Solutions, Inc.

K number K162467

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DQY 2017-01-06

Trapper Exchange Device

Applicant Creganna Medical Aslo Business AS Cregganna Tactx Medical

K number K162253

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DQY 2017-01-05

YOGA Microcatheter

Applicant Codman & Shurtleff, Inc.

K number K162563

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DQY 2016-12-23

AMPLATZER TorqVue 45x45 Delivery Sheath

Applicant Aga Medical COrporation (Wholly Owned by St. Jude Medical CO

K number K163000

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DQY 2016-11-02

Boosting Catheter

Applicant Qxmedical, LLC

K number K160561

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DQY 2016-10-14

R2P SlenGuide

Applicant Ashitaka Factory of Terumo Corporation

K number K161546

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DQY 2016-10-12

Navien Intracranial Support Catheter

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

K number K161152

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DQY 2016-09-22

TrailBlazer Angled Support Catheter

Applicant Medtronic Vascular, Inc.(Formerly Ev3 Inc.)

K number K162384

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DQY 2016-09-21

Surefire Guiding Catheter

Applicant Surefire Medical, Inc.

K number K162359

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DQY 2016-09-19

Super Distal Access (SDA)

Applicant Inneuroco, Inc.

K number K161262

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DQY 2016-09-09

TorqVue Low Profile Delivery Catheter

Applicant Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor

K number K162228

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DQY 2016-08-25

ASAHI Corsair Pro

Applicant Asahi Intecc Co., Ltd.

K number K161126

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DQY 2016-08-04

SIDEKICK and USHER Support Catheters

Applicant Bard Peripheral Vascular, Inc.

K number K161986

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DQY 2016-07-14

Wingman 18 Crossing Catheter

Applicant Reflow Medical, Inc.

K number K160848

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DQY 2016-07-12

ARTLINE

Applicant Health Line International Corporation

K number K160448

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DQY 2016-06-17

CenterCross Ultra Catheter

Applicant Roxwood Medical, Inc.

K number K160681

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DQY 2016-06-14

ASAHI Corsair Armet

Applicant Asahi Intecc Co., Ltd.

K number K161362

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DQY 2016-05-12

Guiding Catheter

Applicant Texasmedical Technologies, Inc.

K number K153703

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DQY 2016-03-11

NovaCross Microcatheter

Applicant Nitiloop , Ltd.

K number K160389

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DQY 2016-03-04

MultiCross Catheter

Applicant Roxwood Medical, Inc.

K number K152957

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DQY 2016-03-04

ASAHI Corsair Armet

Applicant Asahi Intecc Co., Ltd.

K number K152249

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DQY 2016-01-27

8F FlowGate2 Balloon Guide Catheter

Applicant Concentric Medical

K number K153729

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DQY 2016-01-26

CenterCross Ultra Catheter

Applicant Roxwood Medical, Inc.

K number K152456

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DQY 2016-01-22

ASAHI Caravel

Applicant Asahi Intecc Co., Ltd.

K number K152447

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DQY 2016-01-08

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

Applicant Tni Manufacturing, Inc.

K number K152876

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DQY 2013-12-31

UNBALLOON NON-OCCLUSION MODELING CATHETER

Applicant LeMaitre Vascular, Inc.

K number K133026

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DQY 2013-12-20

VIA MICROCATHETER, VIA PLUS MICROCATHETER

Applicant Sequent Medical, Inc.

K number K132652

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DQY 2013-11-22

SOFIA DISTAL ACCESS CATHETER

Applicant MicroVention, Inc.

K number K131482

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DQY 2013-11-15

TRANSGATE GUIDE CATHETER

Applicant Stryker Neurovascular

K number K132542

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DQY 2013-11-01

SILK ROAD ACCESS CATHETER

Applicant Silk Road Medical, Inc.

K number K130649

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DQY 2013-10-24

SHEATHLESS EAUCATH CORONARY GUIDE CATHETER

Applicant Asahi Intecc Co., Ltd.

K number K132556

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DQY 2013-10-22

5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER

Applicant Medtronic, Inc.

K number K132673

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DQY 2013-10-17

RESPIGUIDE DELIVERY SYSTEM

Applicant Respicardia

K number K130378

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DQY 2013-10-11

REVERSE MEDICAL MICROCATHETER

Applicant Reverse Medical Corporation

K number K130858

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DQY 2013-10-03

MODIFIED FLOWGATE BALLOON GUIDE CATHETER

Applicant Concentric Medical, Inc.

K number K131492

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DQY 2013-10-03

OCCLUSION PERFUSION CATHETER

Applicant Advanced Catheter Therapies, Inc.

K number K130525

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DQY 2013-09-27

VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM

Applicant Volcano Corporation

K number K132659

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DQY 2013-09-26

PRIMI SUPPORT CATHETER

Applicant Thermopeutix, Inc.

K number K132701

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DQY 2013-09-19

WINGMAN EXTENDABLE TIP SUPPORT CATHETER

Applicant Reflow Medical

K number K132420

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DQY 2013-08-29

CONCIERGE GUIDING CATHETER

Applicant Merit Medical Systems, Inc.

K number K132409

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DQY 2013-08-23

SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL

Applicant Biotronik, Inc.

K number K131978

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DQY 2013-08-22

PROGIGY SUPPORT CATHETER

Applicant Radius Medical, LLC

K number K130714

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DQY 2013-08-15

AMPLATZER TORQ VUE LP DELIVERY SYSTEM

Applicant St Jude Medical

K number K131063

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DQY 2013-08-12

CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER

Applicant Pendracare International, B.V.

K number K132197

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DQY 2013-08-02

SIDEKICK AND USHER SUPPORT CATHETERS

Applicant C.R. Bard, Inc.

K number K131493

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DQY 2013-06-28

CODA BALLOON CATHETER

Applicant Cook, Inc.

K number K122917

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DQY 2013-06-25

PRIMI AND SECONDI SUPPORT CATHETERS

Applicant Thermopeutix, Inc.

K number K130850

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DQY 2013-05-29

ADROIT GUIDING CATHETER

Applicant Cordis Corp., A Johnson & Johnson Co.

K number K131225

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DQY 2013-04-24

PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM

Applicant Volcano Corporation

K number K122826

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DQY 2013-04-09

ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

Applicant Medtronic, Ireland

K number K123153

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DQY 2013-03-20

CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

Applicant St Jude Medical

K number K130257

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DQY 2013-03-20

CPS AIM UNIVERSAL SLITTABLE INNER CATHETER

Applicant St Jude Medical

K number K130252

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DQY 2013-03-19

GUIDEZILLA GUIDE EXTENSION CATHETER

Applicant Boston Scientific

K number K123765

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DQY 2013-03-19

ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3

Applicant Cook, Inc.

K number K122940

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DQY 2013-01-14

QXMEDICAL ACCESS & SUPPORT CATHETER

Applicant Qxmedical, LLC

K number K123311

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DQY 2013-01-11

SELECTRA 7F CATHETERS

Applicant Biotronik, Inc.

K number K123324

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DQY 2013-01-03

TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM

Applicant Stryker

K number K123452

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DQY 2012-12-21

NHANCER

Applicant Imds Operations B.V.

K number K121077

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DQY 2012-12-14

UNBALLOON NON-OCCLUSIVE MODELING CATHETER

Applicant LeMaitre Vascular, Inc.

K number K123531

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DQY 2012-12-07

REVERSE MEDICAL MICROCATHETER

Applicant Reverse Medical Corporation

K number K122684

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DQY 2012-11-27

MULTICROSS SUPPORT CATHETER

Applicant Roxwood Medical, Inc.

K number K121763

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DQY 2012-11-21

MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254

Applicant Concentric Medical, Inc.

K number K122581

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DQY 2012-11-20

PENUMBRA DDC CATHETERS

Applicant Penumbra, Inc.

K number K122772

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DQY 2012-09-25

ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER

Applicant Medtronic, Inc.

K number K121219

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DQY 2012-08-31

TYSHAK NUCLEUS

Applicant NuMED, Inc.

K number K121859

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DQY 2012-08-30

RUBICON 18 SUPPORT CATHETER

Applicant Boston Scientific Corp

K number K122394

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DQY 2012-08-23

AMPLATZER TORQVUE FX

Applicant Aga Medical Corporation

K number K121611

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DQY 2012-08-15

ARMADA 14XXT PTA CATHETER

Applicant Abbott Vascular

K number K121352

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DQY 2012-08-09

CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH

Applicant Fuji Systems Corp.

K number K120781

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DQY 2012-08-08

UNBALLOON NON-OCCLUSIVE MODELING CATHETER

Applicant LeMaitre Vascular, Inc.

K number K121839

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DQY 2012-08-08

CONVEY GUIDING CATHETER

Applicant Pendracare International, B.V.

K number K120585

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DQY 2012-06-13

CONCIERGE GUIDING CATHETER

Applicant Merit Medical Systems, Inc.

K number K121051

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DQY 2012-05-25

UPSTREAM GR CATHETER

Applicant Upstream Peripheral Technologies

K number K120964

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DQY 2012-05-15

SWITCH-IT CATHETER

Applicant Vascular Solutions, Inc.

K number K120707

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DQY 2012-05-11

CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER

Applicant St. Jude Medical, Cardiac Rhythm Management Divisi

K number K120296

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DQY 2012-04-20

EXCELSIOR XT-27 MICROCATHETER

Applicant Stryker Neurovascular

K number K113778

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DQY 2012-03-20

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER

Applicant Vascular Solutions, Inc.

K number K112100

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DQY 2012-03-15

AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH

Applicant Aga Medical Corporation

K number K120120

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DQY 2012-03-15

CONCENTRIC BALLOON GUIDE CATHETER

Applicant Concentric Medical, Inc.

K number K112404

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DQY 2012-02-24

Q50 PLUS STENT GRAFT BALLOON CATHETER

Applicant Qxmedical, LLC

K number K120381

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DQY 2012-02-24

ENVOY DISTAL ACCESS GUIDING CATHETER

Applicant Codman & Shurtleff, Inc.

K number K120229

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DQY 2012-02-23

UPSTREAM SUPPORT CATHETER

Applicant Upstream Peripheral Technologies

K number K112886

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DQY 2012-02-08

WINGMAN EXTENDABLE TIP SUPPORT CATHETER

Applicant Reflow Medical

K number K120178

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DQY 2012-02-03

MANTARAY CATHETER

Applicant Bridgepoint Medical

K number K120129

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DQY 2012-01-12

FUNNEL GUIDE CATHETER MODEL G1020608

Applicant Lazarus Effect, Inc.

K number K102439

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DQY 2012-01-05

VALET MICRO CATHETER

Applicant Volcano Corporation

K number K112035

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DQY 2012-01-04

BIGBOSS CATHETER

Applicant Bridgepoint Medical

K number K113589

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DQY 2011-12-14

CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)

Applicant Trireme Medical, Inc.

K number K111738

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DQY 2011-12-01

GUIDELINER V2 CATHETER

Applicant Vascular Solutions, Inc.

K number K112082

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DQY 2011-11-17

CLEARWAY RX NB CATHETER

Applicant Atrium Medical Corp.

K number K113112

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DQY 2011-11-09

RUBICON SUPPORT CATHETER

Applicant Boston Scientific

K number K112303

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DQY 2011-11-02

REFLEX BALLON GUIDE CATHETER

Applicant Reverse Medical Corporation

K number K112262

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DQY 2011-10-27

ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

Applicant Medtronic, Inc.

K number K112917

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DQY 2011-10-25

REVIVE INTERMEDIATE CATHETER (REVIVE IC)

Applicant Codman & Shurtleff, Inc.

K number K112828

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DQY 2011-10-17

8FR TURBO - TANDEM SYSTEM

Applicant Spectranetics Corp.

K number K112032

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DQY 2011-10-12

BANTAM CATHETER (280MM BALLOON LENGTHS)

Applicant ClearStream Technologies , Ltd.

K number K112335

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DQY 2011-10-11

ONSET ACCESS CATHETER SYSTEM

Applicant Onset Medical Corporation

K number K112629

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DQY 2011-10-06

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER

Applicant Avinger, Inc.

K number K112579

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DQY 2011-09-26

SELECTRA SLITTER TOOL

Applicant Biotronik, Inc.

K number K112482

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DQY 2011-09-26

SELECTRA ACCESSORY KIT

Applicant Biotronik, Inc.

K number K111839

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