510(k) K122980 ยท DYB Introducer, Catheter
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
| Applicant | Terumo Medical Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Dec 11, 2012 |
| Received | Sep 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122980
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.