# K070357: Flexcath Steerable Sheath & Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Cryocath Technologies, Inc.
- Decided: Dec 28, 2007 after 324 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
No predicates in its family tree.
26 later devices descend from it; 1 cites it directly.
2 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Agilis Steerable Catheter introducer: named in the summary without a submission number
- (no number) Enpath Deflectable Catheter: named in the summary without a submission number

## Most influential descendants
- K081049: Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 (2008), 25 descendants of its own
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10 (2010), 23 descendants of its own
- K123591: Flexcath Advance Steerable Sheath (12 French) (2012), 13 descendants of its own
- K122960: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own

## Indications for use
The FlexCathTM Steerable Sheath & Dilator 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/K070357
Methodology: https://510kreport.com/methodology