Na 106A3

• • Terminated Z-2777-2015 FDA Class II ·initiated 1 Sep 2015

  An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

• • Terminated Z-1452-06 FDA Unclassified (pre-2012) ·initiated 4 Aug 2006

  Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Generic Name

Cardiac cryosurgical system

Model / Reference

106A3

Primary DI / UDI-DI

00643169449596

PMA Number

P020045 ↗

FDA Product Code

LPB, BRW, BRT

GMDN Term

Cardiac cryosurgical system

Device Class

Class III

Regulation Number

868.5820, 880.6760

GUDID distribution status

In Commercial Distribution

Category: Cardiac cryosurgical system

• Na 106A3

  Class III

  GUDID on market

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

  Class II

  FDA 510(k) K102176 Active Cleared 1 Sep 2010

• FlexCath Advance Steerable Sheath and Dilator

  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

See all devices from Medtronic Cryocath, LP →