K161249 is an FDA 510(k) clearance for the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Medtronic (Santa Ana, US). The FDA issued a Cleared decision on August 19, 2016, 108 days after receiving the submission on May 3, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K161249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2016 |
| Decision Date | August 19, 2016 |
| Days to Decision | 108 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |