The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Achieve St Mapping Catheter, Catheter Connecting Cable.
| Device ID | K153139 |
| 510k Number | K153139 |
| Device Name: | Achieve ST Mapping Catheter, Catheter Connecting Cable |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mail Stop MVS46 Mounds View, MN 55112 |
| Contact | Heath Taylor |
| Correspondent | Heath 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000465728 | K153139 | 000 |
| 00763000443214 | K153139 | 000 |
| 00763000280031 | K153139 | 000 |
| 00763000280024 | K153139 | 000 |
| 00763000089917 | K153139 | 000 |
| 00643169636644 | K153139 | 000 |
| 00643169591004 | K153139 | 000 |