Product Code: DWP FDA class 2 21 CFR 870.4475

Dilator, Vessel, Surgical

Cardiovascular

The Surgical Vessel Dilator is a cardiovascular surgical instrument used to widen the lumen of a blood vessel or anastomotic site during open vascular surgery, facilitating the placement of grafts, catheters, or other devices. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWP and it is regulated under 21 CFR 870.4475 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DWP
Device Class: FDA class 2
Regulation Number: 870.4475
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

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 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220981	SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe	Apr 20, 2023	Substantially Equivalent	Fehling Surgical Instruments, Inc.
K183438	Geomed Vascular Dilators	Sep 03, 2019	Substantially Equivalent	Geomed Medizin-Technik GmbH & Co.
K163524	Vessel Dilator	Jun 29, 2017	Substantially Equivalent	Fetzer Medical GmbH & Co. KG
K130896	VASCULAR PROBE, VASCULAR PROBE ES	Apr 24, 2013	Substantially Equivalent	Synovis Life Technologies, Inc.
K100518	INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054	Aug 31, 2010	Substantially Equivalent	Instrumed International, Inc.
K030788	KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS	Jul 12, 2003	Substantially Equivalent	Geister Medizin Technik GmbH
K960312	RDI CARDIAC INSULATION PAD	Apr 19, 1996	Substantially Equivalent	R D Intl.
K912548	LEMAITRE-BOOKWALTER VESSEL DEVICES	Sep 18, 1991	Substantially Equivalent	Vascutech, Inc.
K911475	LAPAROSCOPIC VESSEL ARTICULATOR	Jul 02, 1991	Substantially Equivalent	United States Endoscopy Group, Inc.
K910682	ROBICSEK PROBE/RETRACTOR	May 08, 1991	Substantially Equivalent	Bio-Vascular, Inc.
K905159	FLO-RESTER(R) VESSEL SIZER	Feb 07, 1991	Substantially Equivalent	Bio-Vascular, Inc.
K902143	FOGARTY VESSEL CALIBRATOR	Oct 16, 1990	Substantially Equivalent	Baxter Healthcare Corp
K891786	PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)	Oct 12, 1989	Substantially Equivalent	Pioneering Technologies, Inc.
K833676	SURGICAL VESSEL DILATORS-CATHERIZA-	Mar 19, 1984	Substantially Equivalent	Cimed Intl., Inc.
K832595	VESSEL DILATOR	Aug 31, 1983	Substantially Equivalent	Abbott Laboratories
K822687	REUSABLE FOGARTY FLEXIBLE CALIBRATOR	Oct 04, 1982	Substantially Equivalent	American Edwards Laboratories
K812935	FOGARTY FLEXIBLE PROBE	Nov 16, 1981	Substantially Equivalent	American Edwards Laboratories
K810894	FOGARTY FLEXIBLE CALIBRATOR	May 15, 1981	Substantially Equivalent	American Edwards Laboratories
K792134	BONCHEK-SHILEY VEIN DISTENTION SYSTEM	Dec 04, 1979	Substantially Equivalent	Shiley, Inc.
K790938	SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO	Jun 13, 1979	Substantially Equivalent	Shiley, Inc.