K941445 is an FDA 510(k) clearance for the EXTENSION SET WITH ANTI-SIPHON VALVE. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 29, 1994, 97 days after receiving the submission on March 24, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K941445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1994 |
| Decision Date | June 29, 1994 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |