K881976 is an FDA 510(k) clearance for the CATHETER, INTRAVASCULAR. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on August 4, 1988, 85 days after receiving the submission on May 11, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K881976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1988 |
| Decision Date | August 04, 1988 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |