# K142684: FlexCath Select Steerable Sheath (10 French)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cryocath, LP
- Decided: Nov 6, 2014 after 48 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K070357 (2007). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has 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.
- K132164: Heartspan Steerable Introducer Kit, Merit Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K163268: FlexCath Select Steerable Shealth and Dilator (2017), 0 descendants of its own

## Recalls of this device
- Feb 23, 2015 · Class I · Z-1276-2015: Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

## Indications for use
The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

Source page: https://510kreport.com/device/K142684
Methodology: https://510kreport.com/methodology