The following data is part of a premarket notification filed by Medtronic Cardiorhythm with the FDA for Stablemapr Steerable Intracardiac Catheters.
| Device ID | K981642 |
| 510k Number | K981642 |
| Device Name: | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC CARDIORHYTHM 1312 CROSSMAN AVE. Sunnyvale, CA 94089 -1113 |
| Contact | Kristen Honl |
| Correspondent | Kristen Honl 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 | 1998-05-08 |
| Decision Date | 1998-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169148024 | K981642 | 000 |
| 00643169148000 | K981642 | 000 |