K021232 is an FDA 510(k) clearance for the CONSTELLATION CATHETERS, MODEL 8031M. 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 May 16, 2002, 28 days after receiving the submission on April 18, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K021232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | April 18, 2002 |
| Decision Date | May 16, 2002 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MTD — Catheter, Intracardiac Mapping, High-density Array |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |