Shadow-Caths

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K780643 ↗

FDA Product Code

FJS

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Quinton Single Lumen Catheter

  Class II

  FDA 510(k) K893188 Active Cleared 8 Jun 1989

• 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

See all devices from Quinton, Inc. →