Disposable Transducer

• • Terminated Z-0506-06 FDA Unclassified (pre-2012) ·initiated 9 Jan 2006 ·on shared 510(k) K813464

  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

K813464 ↗

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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