# K192422: Steerable Introducer 12F

- Pathway: 510(k) (Traditional)
- Applicant: Freudenberg Medical, LLC
- Decided: Oct 4, 2019 after 30 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K070357 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123591: Flexcath Advance Steerable Sheath (12 French), Medtronic Cryocath, LP (2012) Summary page 5.

## Indications for use
The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

Source page: https://510kreport.com/device/K192422
Methodology: https://510kreport.com/methodology