510(k) K080154 ยท DQY Catheter, Percutaneous
ACUITY UNIVERSAL CUTTER
| Applicant | Cardiac Pacemakers, Inc., St Paul MN, US |
| Decision | Substantially Equivalent, Mar 20, 2008 |
| Received | Jan 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2020 | Boston Scientific Corporation ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned. Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.