510(k) K130827 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
FIRMAP CATHETER
| Applicant | Topera, Inc., St.Louis MO, US |
| Decision | Substantially Equivalent, Oct 31, 2013 |
| Received | Mar 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130827
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2015 | Abbott Electrophysiology FIRMap 60mm Catheter;
Size: 60 mm; Length 50.4 inches
French Size Diameter: 8.5F (2.84mm)
Model number : USAR064060
Sterile, Rx only
Cardiovascular: For use in cardiac electrophysiology procedures t Terminated |
MTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.