The following data is part of a premarket notification filed by Medtronic with the FDA for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead.
| Device ID | K161249 |
| 510k Number | K161249 |
| Device Name: | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | Medtronic 1801 East Deere Ave Santa Ana, CA 92705 |
| Contact | Debra Taitague |
| Correspondent | Debra Taitague Medtronic 1801 East Deere Ave Santa Ana, CA 92705 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-03 |
| Decision Date | 2016-08-19 |
| Summary: | summary |