The following data is part of a premarket notification filed by Abbott Electrophysiology with the FDA for Firmap Catheter.
| Device ID | K153093 |
| 510k Number | K153093 |
| Device Name: | FIRMap Catheter |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | ABBOTT ELECTROPHYSIOLOGY 1530 OBRIEN DRIVE SUITE B Menlo Park, CA 94025 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo ABBOTT ELECTROPHYSIOLOGY 3668 S. GEYER ROAD SUITE 365 St. Louis, MO 63127 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2016-04-07 |
| Summary: | summary |