K771362 is an FDA 510(k) clearance for the FLU VEN 0150. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Venospital, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977, 35 days after receiving the submission on July 18, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K771362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1977 |
| Decision Date | August 22, 1977 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |