Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10

• • Terminated Z-3186-2011 FDA Unclassified (pre-2012) ·initiated 15 Jul 2011

  Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3FC12. There wave been reports of blood and saline solution leaking out of, and air ingress into the hemostatic valve. This includes reported instances of the introduction of air bubbles through the valve during aspiration of the side port

510(k) Number

K102176 ↗

FDA Product Code

DRA

Device Class

Class II

Regulation

21 CFR Part 870.1280

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Na 106A3

  Class III

  GUDID on market

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  Class II

  FDA 510(k) K202620 Active Cleared 13 Nov 2020

• Flexcath Advance Steerable Sheath (12 French)

  Class II

  FDA 510(k) K123591 Active Cleared 27 Dec 2012

• FlexCath Select Steerable Shealth and Dilator

  Class II

  FDA 510(k) K163268 Active Cleared 2 Feb 2017

• FlexCath Select Steerable Sheath (10 French)

  Class II

  FDA 510(k) K142684 Active Cleared 6 Nov 2014

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  Class III

  FDA PMA P020045 Active Approved 17 Apr 2003

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