K090884 is an FDA 510(k) clearance for the PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on June 29, 2009, 90 days after receiving the submission on March 31, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K090884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2009 |
| Decision Date | June 29, 2009 |
| Days to Decision | 90 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 |