Simpson Peripheral Atherocath

No FDA recalls on record, checked 22 Oct 2026.

Full name

Simpson Peripheral Atherocath(Tm)

510(k) Number

K871011 ↗

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 W/Addit. Size 13F

  Class II

  FDA 510(k) K883346 Active Cleared 26 Sep 1988

See all devices from Devices For Vascular Intervention, Inc. →

• What is the Simpson Peripheral Atherocath used for?

  The Simpson Peripheral Atherocath is a catheter designed for peripheral vascular procedures to treat atherosclerotic lesions. It is specifically used in transluminal interventions to address blockages in peripheral blood vessels.

• How is the Simpson Peripheral Atherocath supplied and what sizes are available?

  The device is supplied in various sizes including 13F. It is intended for single-use only, meaning it should be discarded after one procedure to ensure patient safety and device performance.

• What is the regulatory classification of the Simpson Peripheral Atherocath?

  The Simpson Peripheral Atherocath is classified as a Class II medical device under regulation number 870.1250. It received FDA 510(k) clearance with K number K871011 on May 14, 1987, and was determined to be substantially equivalent to other devices on the market.

• How should the Simpson Peripheral Atherocath be stored?

  The device should be stored according to the manufacturer's instructions to maintain its integrity. While specific storage conditions aren't detailed in the provided information, medical devices of this type are typically stored in a controlled environment away from extreme temperatures and contaminants.