The following data is part of a premarket notification filed by Medtronic Cardiorhythm with the FDA for Performr Series Ep Diagnostic Catheters.
| Device ID | K964272 |
| 510k Number | K964272 |
| Device Name: | PERFORMR SERIES EP DIAGNOSTIC CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC CARDIORHYTHM 1312 CROSSMAN AVE. Sunnyvale, CA 94089 -1113 |
| Contact | Mark Gordon |
| Correspondent | Mark Gordon MEDTRONIC CARDIORHYTHM 1312 CROSSMAN AVE. Sunnyvale, CA 94089 -1113 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1997-01-23 |
| Summary: | summary |