K030830 is an FDA 510(k) clearance for the B. BRAUN NERVE BLOCK CATHETER. This device is classified as a Pump, Infusion, Elastomeric (Class II - Special Controls, product code MEB).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on July 15, 2003, 123 days after receiving the submission on March 14, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K030830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2003 |
| Decision Date | July 15, 2003 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEB — Pump, Infusion, Elastomeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |