Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: DWS FDA class 1

Instruments, Surgical, Cardiovascular

Cardiovascular

View full classification →

Cardiovascular Surgical Instruments are a category of general-purpose hand tools used by surgeons during cardiovascular procedures, including forceps, scissors, retractors, and other instruments designed specifically for use in the heart and major blood vessels. They are classified as FDA Class 1 devices, representing the lowest level of regulatory concern, and are subject to general controls only. The product code is DWS and these instruments are regulated under 21 CFR 870.4500 within the Cardiovascular medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K022238

MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626

Oct 09, 2002

Substantially Equivalent

MEDTRONIC VASCULAR

K964445

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

Jan 30, 1997

Substantially Equivalent

DLP, INC.

K962771

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

Nov 19, 1996

Substantially Equivalent

PILLING WECK, INC.

K955689

RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY

May 15, 1996

Substantially Equivalent

CONTOUR FABRICATORS OF FLORIDA, INC.

K960139

G.E. STERILE ANGIOGRAPHIC TRAY

Apr 19, 1996

Unknown

GE MEDICAL SYSTEMS

K960144

G.E. STERILE CT BIOPSY TRAY

Apr 15, 1996

Unknown

GE MEDICAL SYSTEMS

K960143

G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY

Apr 09, 1996

Unknown

GE MEDICAL SYSTEMS

K934727

REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER

Jan 10, 1994

Substantially Equivalent

CARDIAC PACEMAKERS, INC.

K900379

HYCULT DIAMOND CORONARY BYPASS KNIFE

Mar 19, 1990

Substantially Equivalent

ST. JUDE MEDICAL, INC.

K896307

INSULATION PAD

Jan 19, 1990

Substantially Equivalent

BIO-VASCULAR, INC.

K894738

MODEL 6888 LEAD TUNNELER

Sep 13, 1989

Substantially Equivalent

CARDIAC PACEMAKERS, INC.

K892804

NEWCHILL(TM) CARDIAC INSULATOR

Jul 14, 1989

Substantially Equivalent

ACACIA LABORATORIES, INC.

K893436

MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT

Jul 14, 1989

Substantially Equivalent

PIONEERING TECHNOLOGIES, INC.

K891000

MODIFIED EXTERNAL PAD

May 19, 1989

Substantially Equivalent

INSTROMEDIX, INC.

K890432

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)

Apr 13, 1989

Substantially Equivalent

DEKNATEL, INC.

K890707

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

Apr 10, 1989

Substantially Equivalent

DLP, INC.

K882981

PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP

Sep 27, 1988

Substantially Equivalent

PIONEERING TECHNOLOGIES, INC.

K883135

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

Sep 26, 1988

Substantially Equivalent

PIONEERING TECHNOLOGIES, INC.

K882367

METATECH MICROCLIP APPLICATOR

Aug 25, 1988

Substantially Equivalent

METATECH CORP.

K881796

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE

Jul 26, 1988

Substantially Equivalent

UNIVERSAL MEDICAL INSTRUMENT CORP.

K882479

26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP

Jul 18, 1988

Substantially Equivalent

MEDTRONIC BLOOD SYSTEMS, INC.

K881717

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

Jul 05, 1988

Substantially Equivalent

BUCKMAN CO., INC.

K881392

CARDICAD(TM)

May 31, 1988

Substantially Equivalent

MEDICAL/SURGICAL SPECIALTIES, LTD.

K875016

BIOSURGE MODEL ILVC-1

Feb 29, 1988

Substantially Equivalent

BIOSURGE, INC.

K874960

CARDIOVASCULAR SURGICAL INSTRUMENTS

Feb 05, 1988

Substantially Equivalent

SOLWAY, INC.

K864461

MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY

Nov 24, 1986

Substantially Equivalent

MEDSURG INDUSTRIES, INC.

K861745

VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET

May 13, 1986

Substantially Equivalent

KEELER INSTRUMENTS, INC.

K851825

SCANLAN TUNNELER, SHEATH & TIP

Jul 12, 1985

Substantially Equivalent

SCANLAN INTL., INC.

K851832

NAMAN POTTS COURNAND NEEDLE

Jul 11, 1985

Substantially Equivalent

MANAN MANUFACTURING CO., INC.

K851833

MANAN SELDINGER NEEDLE

Jul 11, 1985

Substantially Equivalent

MANAN MANUFACTURING CO., INC.

K851834

MANAN GWI GUIDE WIRE INTRODUCER

Jul 11, 1985

Substantially Equivalent

MANAN MANUFACTURING CO., INC.

K851152

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR

Jun 24, 1985

Substantially Equivalent

CRYOMEDICS, INC.

K851140

TELEFLEX MEDICAL INTRODUCER NEEDLE

Jun 19, 1985

Substantially Equivalent

Teleflex Medical, Inc.

K850394

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR

Apr 24, 1985

Substantially Equivalent

VASCUTECH, INC.

K844584

GORE-TEX TUNNELER

Jan 24, 1985

Substantially Equivalent

W.L. GORE & ASSOCIATES,INC

K841468

PMA ANGIOGRAPHY TRAY

Jun 05, 1984

Substantially Equivalent

PROFESSIONAL MEDICAL SERVICES

K840305

CATEGORY 1 CIRCULATORY SYSTEM DEVICE

Apr 23, 1984

Substantially Equivalent

IMM ENTERPRISES LTD.

K833547

ROTARY VASCULAR KNIFE

Jan 26, 1984

Substantially Equivalent

FORMEDCO, INC.

K831455

LEATHER VALVE CUTTER

Jul 07, 1983

Substantially Equivalent

AMERICAN V. MUELLER

K823764

SCANLAN SINGLE-USE AORTA PUNCH

Mar 24, 1983

Substantially Equivalent

SCANLAN INTL., INC.

K830471

KELLY-WICK TANNELER

Mar 24, 1983

Substantially Equivalent

INTL. MEDICAL PROSTHETICS RESEARCH

K823094

CARDIAC ELEVATOR

Dec 15, 1982

Substantially Equivalent

CARDIO SURGICAL RESEARCH, INC.

K822829

ROTARY VASCULAR KNIFE

Nov 17, 1982

Substantially Equivalent

MEDCO PRODUCTS, CO., INC.

K821569

LEATHER VALVULOTOME

May 27, 1982

Unknown

AMERICAN V. MUELLER

K820258

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH

Mar 02, 1982

Substantially Equivalent

HOWMEDICA CORP.

K813284

VENOUS CANNULA TRAY

Dec 29, 1981

Substantially Equivalent

CUNNINGHAM WOODLAND, INC.

K810890

NEOLOOPS

Aug 31, 1981

Substantially Equivalent

MEDICAL MARKETING SYSTEMS

K802079

DEKNATEL GOOSEN VASCULAR PUNCH BLADES

Sep 16, 1980

Substantially Equivalent

HOWMEDICA CORP.

K801393

AIR ASPIRATOR NEEDLE

Jun 30, 1980

Substantially Equivalent

TEXAS MEDICAL PRODUCTS, INC.

K800122

HANCOCK AORTIC PUNCH

Feb 01, 1980

Substantially Equivalent

HANCOCK LABORATORIES, INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

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