K003782 is an FDA 510(k) clearance for the CONSTELLATION CATHETER, MODEL 8031. 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 February 14, 2001, 69 days after receiving the submission on December 7, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K003782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 07, 2000 |
| Decision Date | February 14, 2001 |
| Days to Decision | 69 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 |