Disp. Transducer W/Monitoring Kit Trans

• • Terminated Z-1072-2019 FDA Class II ·initiated 27 Nov 2018

  Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.

• • Terminated Z-0506-06 FDA Unclassified (pre-2012) ·initiated 9 Jan 2006 ·on shared 510(k) K831506

  The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K831506 ↗

FDA Product Code

DRS

Device Class

Class II

Regulation

21 CFR Part 870.2850

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Introducer, Cat. #int-05FR.

  Class II

  FDA 510(k) K771042 Active Cleared 13 Jul 1977

• Transducer Dome DS106

  Class II

  FDA 510(k) K833096 Active Cleared 3 Nov 1983

• Intk-08 8 French Introducer Kit W/Side

  Class II

  FDA 510(k) K812325 Active Cleared 21 Sep 1981

• DNC 162 Vinca-Flo

  Class II

  FDA 510(k) K770048 Active Cleared 14 Jan 1977

• Introducer, Cat. #int-06FR.

  Class II

  FDA 510(k) K771041 Active Cleared 13 Jul 1977

• Tall Floor Stand Tfs-01

  Class II

  FDA 510(k) K831939 Active Cleared 19 Jul 1983

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