510(k) K171253
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 by
Medtronic
— Product Code LDF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2017
- Date Received
- April 28, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type