The following data is part of a premarket notification filed by Medtronic with the FDA for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter.
| Device ID | K190132 |
| 510k Number | K190132 |
| Device Name: | 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 | 2019-01-28 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000227609 | K190132 | 000 |
| 00763000227463 | K190132 | 000 |
| 00763000227456 | K190132 | 000 |
| 00763000227449 | K190132 | 000 |
| 00763000227432 | K190132 | 000 |
| 00763000227425 | K190132 | 000 |
| 00763000227418 | K190132 | 000 |
| 00763000227401 | K190132 | 000 |
| 00763000227395 | K190132 | 000 |
| 00763000227388 | K190132 | 000 |
| 00763000227470 | K190132 | 000 |
| 00763000227487 | K190132 | 000 |
| 00763000227494 | K190132 | 000 |
| 00763000227593 | K190132 | 000 |
| 00763000227586 | K190132 | 000 |
| 00763000227579 | K190132 | 000 |
| 00763000227562 | K190132 | 000 |
| 00763000227555 | K190132 | 000 |
| 00763000227548 | K190132 | 000 |
| 00763000227524 | K190132 | 000 |
| 00763000227517 | K190132 | 000 |
| 00763000227500 | K190132 | 000 |
| 00763000227371 | K190132 | 000 |