# 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

- Pathway: 510(k) (Special)
- Applicant: Medtronic
- Decided: May 25, 2017 after 27 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K012454 (2001). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140972: Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing, Medtronic, Inc. (2014) Summary page 4.
- K161249: Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Medtronic (2016) Summary page 4.

## Most influential descendants
- K190716: 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 (2019), 1 descendant of its own
- K242705: Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (2025), 0 descendants of its own

## Indications for use
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY. The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary post-surgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY. The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less/ the device is supplied sterile and is intended for SINGLE USE ONLY. The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary post-surgical pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY

Source page: https://510kreport.com/device/K171253
Methodology: https://510kreport.com/methodology