K163008 is an FDA 510(k) clearance for the CareLink SmartSync Device Manager - Pacing System Analyzer. This device is classified as a Tester, Pacemaker Electrode Function (Class II - Special Controls, product code DTA).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on February 28, 2017, 123 days after receiving the submission on October 28, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3720.
| 510(k) Number | K163008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2016 |
| Decision Date | February 28, 2017 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTA — Tester, Pacemaker Electrode Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3720 |