K895454 is an FDA 510(k) clearance for the SELDINGER SINGLE WALL. This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on November 14, 1989, 70 days after receiving the submission on September 5, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K895454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1989 |
| Decision Date | November 14, 1989 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |