K974008 is an FDA 510(k) clearance for the PFLEIDERER'S INTRATYMPANIC CATHETER. This device is classified as a Tube, Tympanostomy (Class II - Special Controls, product code ETD).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on May 13, 1998, 208 days after receiving the submission on October 17, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3880.
| 510(k) Number | K974008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1997 |
| Decision Date | May 13, 1998 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETD — Tube, Tympanostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3880 |