510(k) K171427 ยท OTD Endovascular Suturing System
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
| Applicant | Medtronic Vascular, Inc., Santa Rosa CA, US |
| Decision | Substantially Equivalent, Jun 13, 2017 |
| Received | May 15, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2017 | Medtronic Vascular, Inc. Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only
The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endov Terminated |
OTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.