FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORONARY VEIN GRAFT TAG MARKER
K Number: K971966
·
Decision Jan 26, 1998
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
2
Review Days
243
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
- CORONARY VEIN GRAFT TAG MARKER
- K Number
- K971966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4650
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-Edge, Inc.
- Date Received
- May 28, 1997
- Decision Date
- January 26, 1998
- 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.
VOSS GRAFT 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 Med-Edge, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882314 | CORONARY VEIN GRAFT MARKER | Aug 4, 1988 | Substantially Equivalent |