K171253 is an FDA 510(k) clearance for the Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 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 May 25, 2017, 27 days after receiving the submission on April 28, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K171253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2017 |
| Decision Date | May 25, 2017 |
| Days to Decision | 27 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 |