Voss Graft Marker

FDA 510(k) K895369 · Voss Medical Products

Substantially Equivalent

510(k) numberK895369

Submission

Device name
Voss Graft Marker
Applicant
Voss Medical Products
San Antonio, TX, US
Received
August 29, 1989
Decision date
September 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPK – Marker, Ostia, Aorto-Saphenous Vein
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4650
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code KPK

510(k)DeviceApplicantDecision
K971966Coronary Vein Graft Tag MarkerKPK · Traditional Med-Edge, Inc.01/26/1998SE
K864919Scanlan (TM) Vein/Graft HolderKPK · Traditional Scanlan Intl., Inc.01/12/1987SE
K864101Cook (R) Vein Graft Ring MarkersKPK · Traditional Cook, Inc.10/30/1986SE
K801637Fluoro-Mark Radiopaque Anatomical Mkr.KPK · Traditional C.R. Bard, Inc.08/27/1980SE
K770802Markers, Stainless SteelKPK · Traditional Cardio-Surgical, Inc.06/27/1977SE

More from Cardio-Surgical, Inc.

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
K885161Voss Vein ClampDXC · Traditional 12/22/1989SE

Questions and answers

When was Voss Graft Marker cleared by the FDA?

Voss Graft Marker (K895369) received a 510(k) decision of Substantially Equivalent on September 27, 1989, 29 days after the submission was received.

What is the product code of K895369?

The FDA product code is KPK – Marker, Ostia, Aorto-Saphenous Vein, a Class II (moderate risk) device regulated under 21 CFR 878.4650.