Atherocath Tip Guard

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Addition of a Tip Guard to the Atherocath(Tm)

510(k) Number

K881088 ↗

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 primary purpose of the Atherocath Tip Guard in vascular procedures?

  The Atherocath Tip Guard is designed to reduce the risk of vessel perforation or damage during peripheral transluminal angioplasty procedures. Its protective tip guard shields the catheter tip during insertion and manipulation, enhancing safety in interventional radiology and cardiology settings.

• Is the Atherocath Tip Guard intended for single-use or reusable applications?

  The Atherocath Tip Guard is explicitly supplied as a single-use, sterile catheter. It is not designed for reuse, as is standard for most sterile medical devices in clinical settings.

• How is the regulatory status of this device determined, and what does it mean for clinical use?

  The device holds an FDA 510(k) clearance (K881088), classified under 21 CFR 870.1250 as a catheter for peripheral transluminal angioplasty. This clearance confirms it is substantially equivalent to predicate devices, meaning it meets FDA safety and effectiveness standards for its intended use in vascular interventions.

• What types of procedures is the Atherocath Tip Guard suitable for, and where is it typically used?

  The device is intended for peripheral vascular procedures, specifically to minimize risks during angioplasty. It is primarily used in interventional radiology and cardiology settings where precise catheter placement is critical.

• Are there any specific storage requirements for the Atherocath Tip Guard before use?

  Since the device is sterile and single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for shelf-life and handling to maintain sterility.