K871885 is an FDA 510(k) clearance for the ESKA-HERRMANN TRACHEOSTOMY VALVE. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on June 8, 1987, 25 days after receiving the submission on May 14, 1987.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K871885 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1987 |
| Decision Date | June 08, 1987 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWL — Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |