# K112541: Z Flex-270TM Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Great Batch Medical
- Decided: Feb 7, 2012 after 159 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: 3 generations back to K070357 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10, Medtronic Cryocath, LP (2010) Summary page 1.

## Recalls of this device
- Sep 6, 2012 · Class II · Z-2459-2012: During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees

## Indications for use
The Z'Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.

Source page: https://510kreport.com/device/K112541
Methodology: https://510kreport.com/methodology