# K152310: HeartLight Deflectable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Cardiofocus, Inc.
- Decided: Feb 24, 2016 after 194 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
The CardioFocus Deflectable Sheath is indicated 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/K152310
Methodology: https://510kreport.com/methodology