510(k) K801637
- Device
- Fluoro-mark Radiopaque Anatomical Mkr.
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K801637
- Product code
- KPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-27
- Date received
- 1980-07-17
- Regulation
- 878.4650
- Classification name
- Marker, Ostia, Aorto-Saphenous Vein
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1643116
- 2528981
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971966 | CORONARY VEIN GRAFT TAG MARKER | Med-Edge, Inc. | 1998-01-26 |
| K895369 | VOSS GRAFT MARKER | Voss Medical Products | 1989-09-27 |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | Scanlan Intl., Inc. | 1987-01-12 |
| K864101 | COOK (R) VEIN GRAFT RING MARKERS | Cook, Inc. | 1986-10-30 |
| K770802 | MARKERS, STAINLESS STEEL | Cardio-Surgical, Inc. | 1977-06-27 |