K895204 is an FDA 510(k) clearance for the EPI-CATH(TM) EPIDURAL CATHETER. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 15, 1989, 90 days after receiving the submission on August 17, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K895204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1989 |
| Decision Date | November 15, 1989 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSO — Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |