The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Achieve Advance Mapping Catheter.
| Device ID | K162892 |
| 510k Number | K162892 |
| Device Name: | Achieve Advance Mapping Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE MAIL STOP MVS46 Mounds View, MN 55112 |
| Contact | Heather Taylor |
| Correspondent | Heather Taylor MEDTRONIC INC. 8200 CORAL SEA STREET NE MAIL STOP MVS46 Mounds View, MN 55112 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169590984 | K162892 | 000 |
| 00643169590960 | K162892 | 000 |