Voss Vein Clamp

FDA 510(k) K885161 · Voss Medical Products

Substantially Equivalent

510(k) numberK885161

Submission

Device name
Voss Vein Clamp
Applicant
Voss Medical Products
San Antonio, TX, US
Received
December 13, 1988
Decision date
December 22, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXC – Clamp, Vascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

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More from Vascular Graft Solutions, Ltd.

510(k)DeviceDecision
K932187Prone PositionerKIL · Traditional 06/01/1993SE
K932186Bypass Leg PositionerFQO · Traditional 06/01/1993SE
K896338Voss Disposable Coronary Bypass Flushing CannulaDWF · Traditional 05/17/1990SE
K895369Voss Graft MarkerKPK · Traditional 09/27/1989SE

Questions and answers

When was Voss Vein Clamp cleared by the FDA?

Voss Vein Clamp (K885161) received a 510(k) decision of Substantially Equivalent on December 22, 1989, 374 days after the submission was received.

What is the product code of K885161?

The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.