The following data is part of a premarket notification filed by Cardiorhythm with the FDA for Torqr Series Diagnostic Ep Catheters.
| Device ID | K923915 |
| 510k Number | K923915 |
| Device Name: | TORQR SERIES DIAGNOSTIC EP CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CARDIORHYTHM 90 WEST PLUMERIA DR. San Jose, CA 95134 |
| Contact | George M Savage |
| Correspondent | George M Savage CARDIORHYTHM 90 WEST PLUMERIA DR. San Jose, CA 95134 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1993-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994947536 | K923915 | 000 |
| 00643169565968 | K923915 | 000 |
| 00643169565951 | K923915 | 000 |
| 00681490024600 | K923915 | 000 |
| 00681490024570 | K923915 | 000 |
| 00681490024495 | K923915 | 000 |
| 00681490024464 | K923915 | 000 |
| 00763000188566 | K923915 | 000 |
| 00763000188559 | K923915 | 000 |
| 00763000188542 | K923915 | 000 |
| 00763000188535 | K923915 | 000 |
| 00763000719302 | K923915 | 000 |
| 00763000719296 | K923915 | 000 |
| 00763000719289 | K923915 | 000 |
| 00643169137509 | K923915 | 000 |
| 00643169137523 | K923915 | 000 |
| 00613994947376 | K923915 | 000 |
| 00613994947529 | K923915 | 000 |
| 00613994947512 | K923915 | 000 |
| 00613994947505 | K923915 | 000 |
| 00613994947482 | K923915 | 000 |
| 00613994947475 | K923915 | 000 |
| 00613994947468 | K923915 | 000 |
| 00613994947451 | K923915 | 000 |
| 00613994947437 | K923915 | 000 |
| 00613994947420 | K923915 | 000 |
| 00613994947413 | K923915 | 000 |
| 00613994947406 | K923915 | 000 |
| 00613994947390 | K923915 | 000 |
| 00613994947383 | K923915 | 000 |
| 00763000719272 | K923915 | 000 |