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
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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 | Device Class | Medical Specialty |
|---|---|---|---|
| KPK | Marker, Ostia, Aorto-Saphenous Vein | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPK), ordered by most recent decision date.
CORONARY VEIN GRAFT TAG MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCANLAN (TM) VEIN/GRAFT HOLDER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COOK (R) VEIN GRAFT RING MARKERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MARKERS, STAINLESS STEEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Voss Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K932187 | PRONE POSITIONER | Jun 1, 1993 | Substantially Equivalent |
| K932186 | BYPASS LEG POSITIONER | Jun 1, 1993 | Substantially Equivalent |
| K896338 | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA | May 17, 1990 | Substantially Equivalent |
| K885161 | VOSS VEIN CLAMP | Dec 22, 1989 | Substantially Equivalent |