K023140 is an FDA 510(k) clearance for the VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 15, 2003, 329 days after receiving the submission on September 20, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K023140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2002 |
| Decision Date | August 15, 2003 |
| Days to Decision | 329 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 |