K130843 is an FDA 510(k) clearance for the SAFESEPT NEEDLE FREE 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 January 8, 2014, 287 days after receiving the submission on March 27, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K130843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2013 |
| Decision Date | January 08, 2014 |
| Days to Decision | 287 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRC - Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |