Instruments, Surgical, Cardiovascular

FDA product code DWS · 71 cleared devices

Class 1 Cardiovascular

Regulation: 21 CFR 870.4500
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 2002-10-09

DWS 2002-10-09

MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626

Applicant Medtronic Vascular

K number K022238

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DWS 1997-01-30

OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)

Applicant Dlp, Inc.

K number K964445

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DWS 1996-11-19

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

Applicant Pilling Weck, Inc.

K number K962771

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DWS 1996-05-15

RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY

Applicant Contour Fabricators of Florida, Inc.

K number K955689

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DWS 1996-04-19

G.E. STERILE ANGIOGRAPHIC TRAY

Applicant GE Medical Systems

K number K960139

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DWS 1996-04-15

G.E. STERILE CT BIOPSY TRAY

Applicant GE Medical Systems

K number K960144

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DWS 1996-04-09

G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY

Applicant GE Medical Systems

K number K960143

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DWS 1994-01-10

REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER

Applicant Cardiac Pacemakers, Inc.

K number K934727

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DWS 1990-03-19

HYCULT DIAMOND CORONARY BYPASS KNIFE

Applicant St. Jude Medical, Inc.

K number K900379

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DWS 1990-01-19

INSULATION PAD

Applicant Bio-Vascular, Inc.

K number K896307

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DWS 1989-09-13

MODEL 6888 LEAD TUNNELER

Applicant Cardiac Pacemakers, Inc.

K number K894738

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DWS 1989-07-14

MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT

Applicant Pioneering Technologies, Inc.

K number K893436

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DWS 1989-07-14

NEWCHILL(TM) CARDIAC INSULATOR

Applicant Acacia Laboratories, Inc.

K number K892804

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DWS 1989-05-19

MODIFIED EXTERNAL PAD

Applicant Instromedix, Inc.

K number K891000

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DWS 1989-04-13

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)

Applicant Deknatel, Inc.

K number K890432

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DWS 1989-04-10

PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL

Applicant Dlp, Inc.

K number K890707

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DWS 1988-09-27

PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP

Applicant Pioneering Technologies, Inc.

K number K882981

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DWS 1988-09-26

PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)

Applicant Pioneering Technologies, Inc.

K number K883135

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DWS 1988-08-25

METATECH MICROCLIP APPLICATOR

Applicant Metatech Corp.

K number K882367

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DWS 1988-07-26

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE

Applicant Universal Medical Instrument Corp.

K number K881796

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DWS 1988-07-18

26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP

Applicant Medtronic Blood Systems, Inc.

K number K882479

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DWS 1988-07-05

PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)

Applicant Buckman Co., Inc.

K number K881717

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DWS 1988-05-31

CARDICAD(TM)

Applicant Medical/Surgical Specialties, Ltd.

K number K881392

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DWS 1988-02-29

BIOSURGE MODEL ILVC-1

Applicant Biosurge, Inc.

K number K875016

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DWS 1988-02-05

CARDIOVASCULAR SURGICAL INSTRUMENTS

Applicant Solway, Inc.

K number K874960

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DWS 1986-11-24

MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY

Applicant Medsurg Industries, Inc.

K number K864461

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DWS 1986-05-13

VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET

Applicant Keeler Instruments, Inc.

K number K861745

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DWS 1985-07-12

SCANLAN TUNNELER, SHEATH & TIP

Applicant Scanlan Intl., Inc.

K number K851825

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DWS 1985-07-11

MANAN GWI GUIDE WIRE INTRODUCER

Applicant Manan Manufacturing Co., Inc.

K number K851834

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DWS 1985-07-11

MANAN SELDINGER NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851833

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DWS 1985-07-11

NAMAN POTTS COURNAND NEEDLE

Applicant Manan Manufacturing Co., Inc.

K number K851832

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DWS 1985-06-24

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR

Applicant Cryomedics, Inc.

K number K851152

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DWS 1985-06-19

TELEFLEX MEDICAL INTRODUCER NEEDLE

Applicant Teleflexmedical, Inc.

K number K851140

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DWS 1985-04-24

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR

Applicant Vascutech, Inc.

K number K850394

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DWS 1985-01-24

GORE-TEX TUNNELER

Applicant W. L. Gore & Associates, Inc.

K number K844584

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DWS 1984-06-05

PMA ANGIOGRAPHY TRAY

Applicant Professional Medical Services

K number K841468

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DWS 1984-04-23

CATEGORY 1 CIRCULATORY SYSTEM DEVICE

Applicant Imm Enterprises , Ltd.

K number K840305

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DWS 1984-01-26

ROTARY VASCULAR KNIFE

Applicant Formedco, Inc.

K number K833547

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DWS 1983-07-07

LEATHER VALVE CUTTER

Applicant American V. Mueller

K number K831455

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DWS 1983-03-24

KELLY-WICK TANNELER

Applicant Intl. Medical Prosthetics Research

K number K830471

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DWS 1983-03-24

SCANLAN SINGLE-USE AORTA PUNCH

Applicant Scanlan Intl., Inc.

K number K823764

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DWS 1982-12-15

CARDIAC ELEVATOR

Applicant Cardio Surgical Research, Inc.

K number K823094

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DWS 1982-11-17

ROTARY VASCULAR KNIFE

Applicant Medco Products, Co., Inc.

K number K822829

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DWS 1982-05-27

LEATHER VALVULOTOME

Applicant American V. Mueller

K number K821569

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DWS 1982-03-02

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH

Applicant Howmedica Corp.

K number K820258

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DWS 1981-12-29

VENOUS CANNULA TRAY

Applicant Cunningham Woodland, Inc.

K number K813284

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DWS 1981-08-31

NEOLOOPS

Applicant Medical Marketing Systems

K number K810890

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DWS 1980-09-16

DEKNATEL GOOSEN VASCULAR PUNCH BLADES

Applicant Howmedica Corp.

K number K802079

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DWS 1980-06-30

AIR ASPIRATOR NEEDLE

Applicant Texas Medical Products, Inc.

K number K801393

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DWS 1980-02-01

HANCOCK AORTIC PUNCH

Applicant Hancock Laboratories, Inc.

K number K800122

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DWS 1979-12-19

CASTROVIEJO VASCULAR SCISSORS

Applicant Edward Weck, Inc.

K number K792576

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DWS 1979-10-26

AORTIC OCCLUDER #000390

Applicant Edward Weck, Inc.

K number K792088

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DWS 1979-09-12

CARDIOVASCULAR INSTRUMENTS-VARIOUS

Applicant Edward Weck, Inc.

K number K791710

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DWS 1979-08-03

SILICONE SURGICAL VESSEL LOOPS

Applicant Conphar, Inc.

K number K791370

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DWS 1979-02-08

GRAFT TUNNELER

Applicant Narco Scientific

K number K790124

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DWS 1978-10-10

SURGITEK DISPOSABLE FLO-RESTER

Applicant Medical Engineering Corp.

K number K781336

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DWS 1978-04-28

AORTIC PUMP

Applicant ETHICON, Inc.

K number K780567

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DWS 1978-02-27

IMPCO DISPOSABLE AORTIC PUNCH

Applicant Thoratec Laboratories Corp.

K number K780247

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DWS 1977-09-12

LEININGEO AORTIC PUNCH #310-395 & 397

Applicant J. Jamner Surgical Instruments, Inc.

K number K771625

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DWS 1977-06-20

HUANG VEIN HOLDER, #21-8011

Applicant Codman & Shurtleff, Inc.

K number K771026

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DWS 1977-02-01

ANASTOMASIS OCCLUDER

Applicant Medical Engineering Corp.

K number K761328

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DWS 1976-12-06

67-8006 DARLING-LINTON AORTIC TOURN.

Applicant Codman & Shurtleff, Inc.

K number K761161

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DWS 1976-11-11

SCISSOR - 1.5MM PROBE POINT, ANGLED

Applicant V. Mueller O.V. Baxter Healthcare Corp.

K number K760792

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DWS 1976-11-11

COOLEY ANGLED SCISSOR - 1MM PROBE POINT

Applicant V. Mueller O.V. Baxter Healthcare Corp.

K number K760791

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DWS 1976-09-21

TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS

Applicant Pilling Co.

K number K760648

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DWS 1976-09-21

CAROTID ARTERY CLAMP W/PILLING LMM

Applicant Pilling Co.

K number K760646

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DWS 1976-09-21

CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP

Applicant Pilling Co.

K number K760645

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DWS 1976-09-17

SMALL VESSEL CANNULA

Applicant Cobe Laboratories, Inc.

K number K760624

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DWS 1976-08-23

CATHETER, ARGYLE THORACIC

Applicant Sherwood Medical Industries

K number K760351

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DWS 1976-07-20

CATHETER, THORACIC DRAIN

Applicant Sherwood Medical Industries

K number K760136

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DWS 1976-07-20

TAPE, VASCULAR, 1/4 DACRON

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K760087

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