Simpson Peripheral Atherocath W/Addit. Size 13F

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883346 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Guiding Catheter (Tip Softness Change)

  Class II

  FDA 510(k) K883981 Active Cleared 3 Nov 1988

• Guiding Catheters 9F JL4

  Class II

  FDA 510(k) K871021 Active Cleared 16 Jun 1987

• Hollow Motor Drive Unit W/ Torque Controller

  Class II

  FDA 510(k) K920707 Active Cleared 23 Nov 1992

• Rotating Hemostatic Valve

  Class II

  FDA 510(k) K911678 Active Cleared 12 Jul 1991

• Modified Simpson Peripheral Atherocath

  Class II

  FDA 510(k) K874706 Active Cleared 4 Jan 1988

• Simpson Peripheral Atherocath

  Class II

  FDA 510(k) K871011 Active Cleared 14 May 1987

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