510(k) K183493 ยท DQY Catheter, Percutaneous
SelectSite C304-HIS Deflectable Catheter System
| Applicant | Medtronic, Inc., Galway, IE |
| Decision | Substantially Equivalent, Mar 15, 2019 |
| Received | Dec 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2022 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.