The following data is part of a premarket notification filed by Rhythmia Medical, Inc with the FDA for Intellamap Orion High Resolution Mapping Catheter.
| Device ID | K143481 |
| 510k Number | K143481 |
| Device Name: | IntellaMap Orion High Resolution Mapping Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | RHYTHMIA MEDICAL, INC 111 SOUTH BEDFORD ST SUITE 205 Burlington, MA 01803 |
| Contact | Frank Jurczak |
| Correspondent | Frank Jurczak RHYTHMIA MEDICAL, INC 111 SOUTH BEDFORD ST SUITE 205 Burlington, MA 01803 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2015-01-08 |
| Summary: | summary |