Tray, Catheterization W/ Catheter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760128 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Prefilled Pulsator Syringe

  Class II

  FDA 510(k) K811009 Active Cleared 12 Jun 1981

• Epidural Trays

  Class II

  FDA 510(k) K842095 Active Cleared 3 Jul 1984

• Syringe, Blood Sampling, Arterial, #4015

  Class II

  FDA 510(k) K770852 Active Cleared 14 Jul 1977

• Arterial Blood Sampling Kits

  Class I

  FDA 510(k) K841486 Active Cleared 23 May 1984

• Tray, Blood Sampling (Pulsator II)

  Class II

  FDA 510(k) K760086 Active Cleared 16 Jul 1976

• Sani Catch Ba

  Class I

  FDA 510(k) K833814 Active Cleared 19 Mar 1984

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