510(k) K143083 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Bio-Medicus Pediatric Cannula and Introducers
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Mar 25, 2015 |
| Received | Oct 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2017 | Covidien LLC GastriSail" Gastric Positioning Device
Product Usage:
The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decom Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.