K190716 is an FDA 510(k) clearance for the Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar 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 8, 2019, 142 days after receiving the submission on March 19, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K190716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2019 |
| Decision Date | August 08, 2019 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| 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 |