# K183174: FlexCath Advance Steerable Sheath and Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cryocath, LP
- Decided: Nov 26, 2018 after 10 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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 4.

## Most influential descendants
- K202620: FlexCath Advance Steerable Sheath and Dilator (2020), 0 descendants of its own

## Indications for use
The FlexCath Advance Steerable Sheath 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/K183174
Methodology: https://510kreport.com/methodology