K171584 is an FDA 510(k) clearance for the B. Braun Tear-Away Introducer Needle. 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 December 22, 2017, 205 days after receiving the submission on May 31, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K171584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2017 |
| Decision Date | December 22, 2017 |
| Days to Decision | 205 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 |