# K210185: CardioCurve Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Talon Surgical
- Decided: Jul 23, 2021 after 179 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K964518 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110450: Agilis NXT Steerable Introducer, St Jude Medical (2011) Summary page 6.
- K111943: Agills PF Delivery System, St. Jude Medical, Cardiac Rhythm Management Divisi (2011) Summary page 6.
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 6.

## Most influential descendants
- K240004: CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer (2024), 0 descendants of its own

## Indications for use
The Talon Surgical CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K210185
Methodology: https://510kreport.com/methodology