K983171 is an FDA 510(k) clearance for the CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM. This device is classified as a Catheter, Intracardiac Mapping, High-density Array (Class II - Special Controls, product code MTD).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on March 11, 1999, 182 days after receiving the submission on September 10, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K983171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1998 |
| Decision Date | March 11, 1999 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MTD — Catheter, Intracardiac Mapping, High-density Array |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |