FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

VOSS GRAFT MARKER

K Number: K895369 · Decision Sep 27, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
5
Review Days
29

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
VOSS GRAFT MARKER
K Number
K895369
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4650
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Voss Medical Products
Date Received
August 29, 1989
Decision Date
September 27, 1989
Product Code
KPK
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KPK Marker, Ostia, Aorto-Saphenous Vein

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KPK), ordered by most recent decision date.

View all

Other Clearances by Voss Medical Products

K Number Device Name
K932187 PRONE POSITIONER
K932186 BYPASS LEG POSITIONER
K896338 VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA
K885161 VOSS VEIN CLAMP