# K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Apr 1, 2009 after 69 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P950022 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960030: Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads, Abbott Medical (1998) Summary page 1.
- P960013: Tendril DX Model 1388T & 1388K Endocardial Pacing Leads, Abbott Medical (1997) Summary page 1.
- P030054: ST Jude Medical Epic HF System, Abbott Medical (2004) Summary page 5.
- P950022: TVL (TM) Lead System, Abbott Medical (1996) Summary page 1.

## Most influential descendants
- K191469: Biotronik Stylets (2019), 0 descendants of its own

## Indications for use
The stylet is intended to aid in the placement of St. Jude Medical transvenous leads.

Source page: https://510kreport.com/device/K090163
Methodology: https://510kreport.com/methodology