The following data is part of a premarket notification filed by Medtronic with the FDA for Marinr Steerable Intracardiac Electrode Catheter, Stablemapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter.
| Device ID | K183547 |
| 510k Number | K183547 |
| Device Name: | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Medtronic 8200 Coral Sea St NE Mounds View, MN 55112 |
| Contact | Matthew Lobeck |
| Correspondent | Matthew Lobeck Medtronic 8200 Coral Sea St NE Mounds View, MN 55112 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000227913 | K183547 | 000 |
| 00763000227906 | K183547 | 000 |
| 00763000227890 | K183547 | 000 |
| 00763000227869 | K183547 | 000 |
| 00763000227852 | K183547 | 000 |
| 00763000227845 | K183547 | 000 |
| 00763000227883 | K183547 | 000 |
| 00763000227876 | K183547 | 000 |