# K191469: Biotronik Stylets

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Aug 1, 2019 after 59 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: 2 generations back to P950022 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078, St Jude Medical (2009) Summary page 4.

## Indications for use
The BIOTRONIK Stylets are used in conjunction with the implantation of implantable systems (leads and pacemakers or ICD). Therefore, the same indications and contraindications that apply for the designated active implant and leads, also apply for stylets.

Source page: https://510kreport.com/device/K191469
Methodology: https://510kreport.com/methodology