The following data is part of a premarket notification filed by Medtronic Cardiorhythm with the FDA for Marinr Series Ep Diagnostic Catheters.
| Device ID | K931794 |
| 510k Number | K931794 |
| Device Name: | MARINR SERIES EP DIAGNOSTIC CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC CARDIORHYTHM 130 RIO ROBLES San Jose, CA 95134 -1806 |
| Contact | Craig J Coombs |
| Correspondent | Craig J Coombs 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 | 1993-04-12 |
| Decision Date | 1994-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994947239 | K931794 | 000 |