510(k) K142182 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
FRIMAP ADAPTER CONNECTOR (MAC)
| Applicant | Topera, Inc., St.Louis MO, US |
| Decision | Substantially Equivalent, Sep 9, 2014 |
| Received | Aug 8, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2022 | Abbott FIRMap" Catheter, 60mm Basket Terminated |
MTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.