Z Flex-270TM Steerable Sheath

• • Terminated Z-2459-2012 FDA Class II ·initiated 6 Sep 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 of damage that could pose an embolic risk to a patient.

510(k) Number

K112541 ↗

FDA Product Code

DRA

Device Class

Class II

Regulation

21 CFR Part 870.1280

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Z Flex-270 Steerable Sheath primarily used for in clinical settings?

  The Z Flex-270 Steerable Sheath is designed for percutaneous vascular and cardiac access, specifically to aid in interventional cardiology procedures. Its flexible 12 French shaft and uni-directional tip deflection mechanism allow for precise navigation through coronary and peripheral blood vessels, making it useful for guiding catheters or other instruments during cardiac interventions.

• Is the Z Flex-270 Steerable Sheath intended for single-use or reusable applications?

  The Z Flex-270 Steerable Sheath is explicitly supplied as a single-use device. It is sterilized via ethylene oxide, which means it should not be reused after one procedure to ensure patient safety and sterility.

• How should the Z Flex-270 Steerable Sheath be stored to maintain its integrity?

  The sheath must be stored in a way that protects it from moisture and extreme temperatures. Since it is non-sterile in its packaging, it should also be kept in a clean, dry environment until ready for use, following ethylene oxide sterilization guidelines.

• What size is the shaft of the Z Flex-270 Steerable Sheath, and how does that affect its use?

  The sheath features a 12 French shaft, which provides a balance of flexibility and strength for navigating coronary and peripheral vasculature. This size is standard for many interventional cardiology procedures, allowing compatibility with commonly used guidewires and catheters while maintaining maneuverability in tight or tortuous blood vessels.

• What regulatory pathway was followed for FDA clearance of the Z Flex-270 Steerable Sheath?

  The Z Flex-270 Steerable Sheath received FDA 510(k) clearance (K112541) under the Traditional 510(k) Review pathway, with a decision date of February 7, 2012. It was classified as substantially equivalent to predicate devices and falls under FDA regulation 870.1280 for steerable catheters, with an advisory committee review by the Cardiovascular (CV) Panel.