K122980 is an FDA 510(k) clearance for the GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on December 11, 2012, 76 days after receiving the submission on September 26, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K122980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2012 |
| Decision Date | December 11, 2012 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |