K801637 is an FDA 510(k) clearance for the FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.. This device is classified as a Marker, Ostia, Aorto-saphenous Vein (Class II - Special Controls, product code KPK).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980, 41 days after receiving the submission on July 17, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 878.4650.
| 510(k) Number | K801637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1980 |
| Decision Date | August 27, 1980 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KPK — Marker, Ostia, Aorto-saphenous Vein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4650 |