K942046 is an FDA 510(k) clearance for the PHARMACIA DELTEC 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 October 4, 1994, 159 days after receiving the submission on April 28, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K942046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1994 |
| Decision Date | October 04, 1994 |
| Days to Decision | 159 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 |