# P960013: Tendril DX Model 1388T & 1388K Endocardial Pacing Leads

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Jun 20, 1997 after 406 days
- Product code: NVN (Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 (2009), 1 descendant of its own
- K191469: Biotronik Stylets (2019), 0 descendants of its own
- K080924: Mond Rvot Stylet Models 4140, 4141, 4150, 4151 (2008), 0 descendants of its own

Source page: https://510kreport.com/device/P960013
Methodology: https://510kreport.com/methodology