K153139 is an FDA 510(k) clearance for the Achieve ST Mapping Catheter, Catheter Connecting Cable. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on May 6, 2016, 189 days after receiving the submission on October 30, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K153139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2015 |
| Decision Date | May 06, 2016 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |