510(k) K983171 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
| Applicant | Boston Scientific Corp, San Jose CA, US |
| Decision | Substantially Equivalent, Mar 11, 1999 |
| Received | Sep 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983171
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2005 | Boston Scientific Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075 Terminated |
MTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.