K062005 is an FDA 510(k) clearance for the PORTEX EPIDURAL CATHETER. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on October 18, 2006, 93 days after receiving the submission on July 17, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K062005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2006 |
| Decision Date | October 18, 2006 |
| Days to Decision | 93 days |
| Submission Type | Special |
| 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 |