K811463 is an FDA 510(k) clearance for the AUTO-SYRINGE MICRO VOLUME EXTENSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981, 17 days after receiving the submission on May 26, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K811463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1981 |
| Decision Date | June 12, 1981 |
| Days to Decision | 17 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 |