# K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10

- Pathway: 510(k) (Special)
- Applicant: Medtronic Cryocath, LP
- Decided: Sep 1, 2010 after 29 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070357 (2007). 2 ancestors in all.
23 later devices descend from it; 3 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081049: Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12, Cryocath Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K123591: Flexcath Advance Steerable Sheath (12 French) (2012), 13 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own

## Recalls of this device
- Jul 15, 2011 · Not classified · Z-3186-2011: Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3FC12. There wave been reports of blood an

## Indications for use
The FlexCath 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/K102176
Methodology: https://510kreport.com/methodology