K897194 is an FDA 510(k) clearance for the PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on June 18, 1990, 171 days after receiving the submission on December 29, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K897194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1989 |
| Decision Date | June 18, 1990 |
| Days to Decision | 171 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 |