Quinton Single Lumen Catheter

• • Terminated Z-1955-2019 FDA Class II ·initiated 29 Apr 2019 ·via K893188, on the same 510(k)

  The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K893188 ↗

FDA Product Code

MPB

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Stainless Steel Guide Wire

  Class II

  FDA 510(k) K831839 Active Cleared 18 Jul 1983

• Medtrack Treadmill

  Class I

  FDA 510(k) K911751 Active Cleared 29 May 1991

• Patient by-Pass

  Class I

  FDA 510(k) K771422 Active Cleared 3 Jan 1978

• Quinton Lte Electrode

  Class II

  FDA 510(k) K810563 Active Cleared 17 Mar 1981

• Model 845T Imaging/Ergometer Table

  Class I

  FDA 510(k) K781500 Active Cleared 14 Sep 1978

• Hemocath

  Class II

  FDA 510(k) K840415 Active Cleared 20 Apr 1984

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