510(k) K162228 ยท DQY Catheter, Percutaneous
TorqVue Low Profile Delivery Catheter
| Applicant | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor, Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 9, 2016 |
| Received | Aug 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Abbott Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.