Catheter, Peripheral, Atherectomy

FDA product code MCW · 133 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.4875
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1990-09-14 – 2026-04-10

MCW 2003-09-16

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060

Applicant Idev Technologies, Inc.

K number K030504

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MCW 2003-06-20

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406

Applicant Fox Hollow Technologies

K number K024243

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MCW 2003-05-27

REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Applicant Rex Medical

K number K031610

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MCW 2002-12-02

SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM

Applicant Bacchus Vascular, Inc.

K number K022640

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MCW 2002-03-06

XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL

Applicant Xtrak Medical, Inc.

K number K013473

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MCW 2001-06-06

BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755

Applicant Bacchus Vascular, Inc.

K number K003570

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MCW 2000-05-04

BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD

Applicant Baxter Edwards

K number K993816

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MCW 2000-04-28

POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002

Applicant Possis Medical, Inc.

K number K993564

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MCW 1999-11-24

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER

Applicant Boston Scientific Corporation Northwest Technology

K number K993648

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MCW 1999-05-04

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65

Applicant Arrow Intl., Inc.

K number K990829

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MCW 1999-02-23

OASIS THROMBECTOMY CATHETER SYSTEM

Applicant Boston Scientific Corp

K number K982363

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MCW 1998-11-18

AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100

Applicant Microvena Corp.

K number K982657

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MCW 1998-02-06

THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)

Applicant Micro Therapeutics, Inc.

K number K973669

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MCW 1997-10-08

GELBFISH ENDO-VAC SYSTEM

Applicant Gary A. Gelbfish

K number K970233

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MCW 1997-09-19

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)

Applicant Microvena Corp.

K number K971984

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MCW 1997-08-29

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER

Applicant Boston Scientific Corp

K number K970296

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MCW 1997-08-08

THROMBOLYTIC BRUSH CATHETER

Applicant Micro Therapeutics, Inc.

K number K963925

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MCW 1997-07-25

ARROW-TREROTOLA PTD CATHETER

Applicant Arrow Intl., Inc.

K number K970080

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MCW 1996-12-03

POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P

Applicant Possis Medical, Inc.

K number K960970

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MCW 1996-08-13

THE AMPLATZ THROMBECTOMY DEVICE

Applicant Microvena Corp.

K number K954205

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MCW 1996-04-25

ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

Applicant Heart Technology Mfg., Inc.

K number K960379

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MCW 1996-01-18

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY

Applicant Heart Technology Mfg., Inc.

K number K954604

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MCW 1995-12-22

ROTABLATOR ROTATIONAL ANGIOPLASTY

Applicant Heart Technology Mfg., Inc.

K number K953997

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MCW 1995-02-07

GRAFT THROMBECTOMY INSTRUMENTS

Applicant Intramed Laboratories, Inc.

K number K942457

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MCW 1994-03-10

MICROTRACK

Applicant Devices For Vascular Intervention, Inc.

K number K935929

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MCW 1993-08-24

ROTABLATOR, MODIFICATION

Applicant Heart Technology, Inc.

K number K933238

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MCW 1993-01-13

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM

Applicant Intensive Technology, Inc.

K number K922970

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MCW 1992-12-08

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Applicant Hearing Tech, Inc.

K number K924712

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MCW 1992-11-23

HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER

Applicant Devices For Vascular Intervention, Inc.

K number K920707

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MCW 1992-02-19

TRAC-WRIGHT TRAC 10 CATHETER

Applicant Dow Corning Wright

K number K915238

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MCW 1991-09-06

HEART TECHNOLOGY ROTABLATOR WIRECLIP

Applicant Heart Technology, Inc.

K number K913450

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MCW 1990-12-27

THERATEK GROUP EXCHANGE CATHETER

Applicant Dow Corning Wright

K number K904680

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MCW 1990-09-14

ROTABLATOR

Applicant Heart Technology, Inc.

K number K901206

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