510(k) K131063 ยท DQY Catheter, Percutaneous
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
| Applicant | St Jude Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 15, 2013 |
| Received | Apr 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Abbott Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.