K081986 is an FDA 510(k) clearance for the SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE. This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on November 14, 2008, 123 days after receiving the submission on July 14, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K081986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2008 |
| Decision Date | November 14, 2008 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRC - Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |