K241372 is an FDA 510(k) clearance for the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™. This device is classified as a Catheter, Intracardiac Mapping, High-density Array (Class II - Special Controls, product code MTD).
Submitted by Abbott Medical (Plymouth, US). The FDA issued a Cleared decision on July 9, 2024, 55 days after receiving the submission on May 15, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K241372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2024 |
| Decision Date | July 09, 2024 |
| Days to Decision | 55 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 |