K981624 is an FDA 510(k) clearance for the FLO-THRU. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 4, 1998, 89 days after receiving the submission on May 7, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K981624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1998 |
| Decision Date | August 04, 1998 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |