510(k) K140036 ยท OTD Endovascular Suturing System
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
| Applicant | Aptus Endosystems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 6, 2014 |
| Received | Jan 7, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140036
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.