Product Code: DWS FDA class 1 21 CFR 870.4500

Instruments, Surgical, Cardiovascular

Cardiovascular

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.

View on FDA

510(k)s

FEI Numbers

313

Registration Numbers

313

Unique Applicants

Years Active

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Basic Information

Product Code: DWS
Device Class: FDA class 1
Regulation Number: 870.4500
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 71 510(k) clearances via K numbers.

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.
K893436	MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT	Jul 14, 1989	Substantially Equivalent	Pioneering Technologies, Inc.
K892804	NEWCHILL(TM) CARDIAC INSULATOR	Jul 14, 1989	Substantially Equivalent	Acacia Laboratories, 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.
K851834	MANAN GWI GUIDE WIRE INTRODUCER	Jul 11, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851833	MANAN SELDINGER NEEDLE	Jul 11, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851832	NAMAN POTTS COURNAND NEEDLE	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	Teleflexmedical, 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
K830471	KELLY-WICK TANNELER	Mar 24, 1983	Substantially Equivalent	Intl. Medical Prosthetics Research
K823764	SCANLAN SINGLE-USE AORTA PUNCH	Mar 24, 1983	Substantially Equivalent	Scanlan Intl., Inc.
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.
K792576	CASTROVIEJO VASCULAR SCISSORS	Dec 19, 1979	Substantially Equivalent	Edward Weck, Inc.
K792088	AORTIC OCCLUDER #000390	Oct 26, 1979	Substantially Equivalent	Edward Weck, Inc.
K791710	CARDIOVASCULAR INSTRUMENTS-VARIOUS	Sep 12, 1979	Substantially Equivalent	Edward Weck, Inc.
K791370	SILICONE SURGICAL VESSEL LOOPS	Aug 03, 1979	Substantially Equivalent	Conphar, Inc.
K790124	GRAFT TUNNELER	Feb 08, 1979	Substantially Equivalent	Narco Scientific
K781336	SURGITEK DISPOSABLE FLO-RESTER	Oct 10, 1978	Substantially Equivalent	Medical Engineering Corp.
K780567	AORTIC PUMP	Apr 28, 1978	Substantially Equivalent	ETHICON, Inc.
K780247	IMPCO DISPOSABLE AORTIC PUNCH	Feb 27, 1978	Substantially Equivalent	Thoratec Laboratories Corp.
K771625	LEININGEO AORTIC PUNCH #310-395 & 397	Sep 12, 1977	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.
K771026	HUANG VEIN HOLDER, #21-8011	Jun 20, 1977	Substantially Equivalent	Codman & Shurtleff, Inc.
K761328	ANASTOMASIS OCCLUDER	Feb 01, 1977	Substantially Equivalent	Medical Engineering Corp.
K761161	67-8006 DARLING-LINTON AORTIC TOURN.	Dec 06, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760792	SCISSOR - 1.5MM PROBE POINT, ANGLED	Nov 11, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760791	COOLEY ANGLED SCISSOR - 1MM PROBE POINT	Nov 11, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760648	TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS	Sep 21, 1976	Substantially Equivalent	Pilling Co.
K760646	CAROTID ARTERY CLAMP W/PILLING LMM	Sep 21, 1976	Substantially Equivalent	Pilling Co.
K760645	CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP	Sep 21, 1976	Substantially Equivalent	Pilling Co.
K760624	SMALL VESSEL CANNULA	Sep 17, 1976	Substantially Equivalent	Cobe Laboratories, Inc.
K760351	CATHETER, ARGYLE THORACIC	Aug 23, 1976	Substantially Equivalent	Sherwood Medical Industries
K760136	CATHETER, THORACIC DRAIN	Jul 20, 1976	Substantially Equivalent	Sherwood Medical Industries
K760087	TAPE, VASCULAR, 1/4 DACRON	Jul 20, 1976	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.