The following data is part of a premarket notification filed by Medtronic with the FDA for 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.
| Device ID | K190716 |
| 510k Number | K190716 |
| Device Name: | 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 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | Medtronic 1851 East Deere Ave. Santa Ana, CA 92705 |
| Contact | Joven Almazan |
| Correspondent | Joven Almazan Medtronic 1851 East Deere Ave. Santa Ana, CA 92705 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-19 |
| Decision Date | 2019-08-08 |