The following data is part of a premarket notification filed by Medtronic Cardiorhythm with the FDA for Platinum Series Ep Diagnostic Catheters.
| Device ID | K953185 |
| 510k Number | K953185 |
| Device Name: | PLATINUM SERIES EP DIAGNOSTIC CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC CARDIORHYTHM 130 RIO ROBLES San Jose, CA 95134 -1806 |
| Contact | Keith V Rohrbach |
| Correspondent | Keith V Rohrbach MEDTRONIC CARDIORHYTHM 130 RIO ROBLES San Jose, CA 95134 -1806 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1996-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169139602 | K953185 | 000 |
| 00643169139596 | K953185 | 000 |
| 00643169139558 | K953185 | 000 |
| 00643169139541 | K953185 | 000 |
| 00643169139534 | K953185 | 000 |
| 00643169139510 | K953185 | 000 |
| 00643169139503 | K953185 | 000 |