K230253 is an FDA 510(k) clearance for the OPTRELL™ Mapping Catheter with TRUEref™ Technology. This device is classified as a Catheter, Intracardiac Mapping, High-density Array (Class II - Special Controls, product code MTD).
Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on March 2, 2023, 30 days after receiving the submission on January 31, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K230253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2023 |
| Decision Date | March 02, 2023 |
| Days to Decision | 30 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 |