Catheter, Peripheral, Atherectomy

MCW 2025-04-25

FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

Applicant Cardio Flow Inc.,

K number K250723

MCW 2025-03-13

Turbo-Elite Laser Atherectomy Catheter

Applicant Spectranetics

K number K250385

MCW 2025-01-30

Rotarex Atherectomy System

Applicant Bard Peripheral Vascular, Inc.

K number K242757

MCW 2024-11-05

FreedomFlow™ Orbital Circumferential Atherectomy System

Applicant Cardio Flow Inc.,

K number K242947

MCW 2024-06-27

Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

Applicant Eximo Medical, Ltd.

K number K241553

MCW 2024-02-15

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)

Applicant Cardio Flow Inc.,

K number K233483

MCW 2023-12-15

Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

Applicant Eximo Medical, Ltd.

K number K233668

MCW 2023-09-27

FreedomFlow Orbital Circumferential Atherectomy System

Applicant Cardio Flow Inc.,

K number K231538

MCW 2023-06-09

Auryon Atherectomy System

Applicant Eximo Medical, Ltd.

K number K230709

MCW 2023-06-06

Pantheris LV Atherectomy Catheter

Applicant Avinger, Inc.

K number K230005

MCW 2022-12-08

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K number K222837

MCW 2022-09-26

Auryon Atherectomy Catheters

Applicant Eximo Medical, Ltd.

K number K220116

MCW 2022-09-06

ROTAPRO Rotational Atherectomy System

Applicant Boston Scientific Corporation

K number K220962

MCW 2022-06-09

Auryon Atherectomy System

Applicant Eximo Medical, Ltd.

K number K221077

MCW 2022-04-27

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

Applicant Cardiovascualr Systems, Inc.

K number K220568

MCW 2022-03-01

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

K number K220109

MCW 2021-12-15

Revolution Peripheral Atherectomy System

Applicant Rex Medical, L.P.

K number K212351

MCW 2021-11-16

Pantheris System

Applicant Avinger, Inc.

K number K212047

MCW 2021-09-14

Rotarex Atherectomy System

Applicant C.R. Bard, Inc.

K number K211738

MCW 2021-09-14

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

K number K210586

MCW 2021-08-24

TurboHawk Plus Directional Atherectomy System

Applicant Medtronic, Inc.

K number K212027

MCW 2021-06-14

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K number K211518

MCW 2020-12-02

Auryon Atherectomy System

Applicant Eximo Medical, Ltd.

K number K202835

MCW 2020-11-19

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

K number K203008

MCW 2019-09-12

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

Applicant Rex Medical, L.P.

K number K191419

MCW 2019-07-02

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System

K number K190634

MCW 2019-04-09

Pantheris SV

Applicant Avinger, Inc.

K number K182341

MCW 2018-12-20

Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K number K182972

MCW 2018-12-17

Phoenix 2.4mm Atherectomy Plus System

Applicant Volcano Atheromed, Inc.

K number K181877

MCW 2018-12-13

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

K number K182397

MCW 2018-10-05

B-Laser Atherectomy System

Applicant Eximo Medical, Ltd.

K number K181642

MCW 2018-05-22

Pantheris System

Applicant Avinger, Inc.

K number K173862

MCW 2018-04-17

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

K number K180416

MCW 2018-04-12

Straub Endovascular System

Applicant Straub Medical AG

K number K172315

MCW 2018-04-05

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K number K180694

MCW 2017-11-27

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K number K172687

MCW 2017-10-30

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

Applicant Avinger, Inc.

K number K172236

MCW 2017-08-24

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K number K172386

MCW 2017-06-16

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

Applicant Medtronic Vascular, Inc.

K number K170191

MCW 2017-06-09

Diamondback 360 Peripheral Orbital Atherectomy System

K number K170792

MCW 2017-04-07

Spectranetics Turbo-Elite Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K number K170059

MCW 2017-01-05

Turbo-Power (2.0mm) Laser Atherectomy Catheters

Applicant Spectranetics, Inc.

K number K162561

MCW 2016-12-21

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

Applicant Avinger, Inc.

K number K163264

MCW 2016-10-18

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

Applicant Avinger, Inc.

K number K162326

MCW 2016-10-14

HawkOne Directional Atherectomy System

Applicant Medtronic Vascular, Inc.

K number K161361

MCW 2016-04-21

Pantheris Catheter

Applicant Avinger, Inc.

K number K160827

MCW 2016-03-01

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

Applicant Avinger, Inc.

K number K153460

MCW 2013-12-20

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS

Applicant Boston Scientific Corp

K number K133566

MCW 2013-11-22

DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

Applicant Cardiovascular Systems Incorporated

K number K133399

MCW 2013-06-24

STEALTH 360 ORBITAL PAD SYSTEM

Applicant Cardio Systems, Inc.

K number K131092

MCW 2013-04-10

JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM

Applicant Medrad, Inc.

K number K130637

MCW 2013-01-25

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035

Applicant Spectranetics Corp.

K number K123632

MCW 2012-10-25

STEALTH 360 ORBITAL PAD SYSTEM

K number K122987

MCW 2012-10-19

JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM

Applicant Medrad, Inc.

K number K122916

MCW 2012-09-13

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS

Applicant Boston Scientific Corp

K number K121774

MCW 2012-06-01

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Applicant Rex Medical

K number K120346

MCW 2012-02-24

JETSTREAM NAVITUS L SYSTEM

K number K120242

MCW 2011-10-27

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Applicant Ev3, Inc.

K number K111723

MCW 2011-07-26

DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM

K number K111388

MCW 2011-06-01

JETSTREAM G3 (R) SF 1.6 SYSTEM

K number K111229

MCW 2011-04-20

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

K number K110626

MCW 2011-03-11

STEALTH 360 ORBITAL PAD SYSTEM

K number K110389

MCW 2011-01-05

TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM

Applicant Ev3, Inc.

K number K103618

MCW 2010-06-11

JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON

K number K101334

MCW 2010-06-02

JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100

K number K101221

MCW 2010-05-19

JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

K number K100462

MCW 2010-02-18

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)

Applicant Rex Medical

K number K091029

MCW 2010-01-25

TURBO-TANDEM SYSTEM MODEL 472-110

Applicant Spectranetics Corp.

K number K094036

MCW 2010-01-21

JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)

K number K093918

MCW 2009-12-01

JETSTREAM G3 SYSTEM

K number K093456

MCW 2009-11-06

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Applicant Ev3, Inc.

K number K093301

MCW 2009-09-03

JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)

K number K092332

MCW 2009-06-19

JETSTREAM G2 NXT SYSTEM, MODEL PV20300

K number K091509

MCW 2009-03-20

DIAMONDBACK 360 DBX

K number K090521

MCW 2009-03-11

JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

K number K090325

MCW 2009-01-23

JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300

K number K083489

MCW 2009-01-13

JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

K number K083837

MCW 2008-10-31

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT

K number K082981

MCW 2008-10-06

JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100

K number K082664

MCW 2008-08-29

MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM

K number K082186

MCW 2008-08-14

MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

Applicant Cardio Systems, Inc.

K number K081944

MCW 2008-07-17

PATHWAY PV ATHERECTOMY SYSTEM

K number K081328

MCW 2008-02-12

SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

Applicant Fox Hollow Technologies

K number K071432

MCW 2007-11-09

MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

K number K072748

MCW 2007-10-25

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

K number K072800

MCW 2007-08-30

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

K number K071427

MCW 2007-08-23

THROMCAT THROMBECTOMY CATHETER SYSTEM

Applicant Kensey Nash Corp.

K number K072195

MCW 2007-08-22

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

K number K071350

MCW 2006-10-23

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

Applicant Foxhollow Technologies, Inc.

K number K061188

MCW 2006-05-18

MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300

Applicant Foxhollow Technologies, Inc.

K number K061063

MCW 2006-04-28

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Applicant Rex Medical, L.P.

K number K060904

MCW 2006-04-25

THROMCAT THROMBECTOMY CATHETER SYSTEM

Applicant Kensey Nash Corp.

K number K060016

MCW 2006-01-13

MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,

Applicant Fox Hollow Technologies

K number K053460

MCW 2005-02-18

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300

Applicant Fox Hollow Technologies

K number K043553

MCW 2005-01-31

ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

Applicant Cardiovascular Systems Incorporated

K number K041630

MCW 2004-09-08

X-SIZER CATHETER SYSTEM

Applicant Ev3 Corporation

K number K021096

MCW 2004-02-26

CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT

Applicant Rex Medical

K number K040252

MCW 2004-02-04

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110

Applicant Bacchus Vascular, Inc.

K number K033997

MCW 2003-12-16

CLEANER II ROTATIONAL THROMBECTOMY SYSTEM

Applicant Rex Medical

K number K033793