K231242 is an FDA 510(k) clearance for the Perifix FX Catheter. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on September 15, 2023, 137 days after receiving the submission on May 1, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K231242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2023 |
| Decision Date | September 15, 2023 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSO — Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |