510(k) K121168 ยท OTD Endovascular Suturing System
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
| Applicant | Aptus Endosystems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 8, 2012 |
| Received | Apr 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121168
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.