Softip Catheter

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

510(k) Number

K834275 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Schneider-Shiley Angioport(Tm) Ptca Intro W/Hemo

  Class II

  FDA 510(k) K873195 Active Cleared 15 Dec 1987

• Softip Coronary Sinus Cardioplegia Catheter

  Class II

  FDA 510(k) K863342 Active Cleared 3 Mar 1987

• Angiomedic's Catheter-Diagnostic Intravascular

  Class II

  FDA 510(k) K850271 Active Cleared 3 Apr 1985

• Schneider-Shiley SofTrac-PTA Angio. Catheter

  Class II

  FDA 510(k) K872542 Active Cleared 14 Sep 1987

• Angiomedics Cath Sheath Introduc W/Hemostasis Valv

  Class II

  FDA 510(k) K861238 Active Cleared 16 Jul 1986

• Angiomedics Softip Catheter

  Class II

  FDA 510(k) K852872 Active Cleared 11 Oct 1985

See all devices from Angiomedics, Inc. →

• What is the Softip Catheter used for?

  The Softip Catheter is a cardiovascular catheter designed for use in procedures requiring catheter-based access within the cardiovascular system. It is classified under product code DQO and manufactured by Angiomedics, Inc.

• What is the regulatory status of the Softip Catheter?

  The Softip Catheter was cleared by the FDA through a traditional 510(k) submission (K834275) with a decision of substantially equivalent on February 4, 1984. It is manufactured by Angiomedics, Inc. in Walker, Michigan, United States.

• Is the Softip Catheter single-use or reusable?

  The device data does not specify whether the Softip Catheter is designed for single-use or multiple uses. For proper usage instructions and sterilization procedures, please refer to the manufacturer's documentation or contact Angiomedics, Inc. directly.

• What sizes and models of the Softip Catheter are available?

  The provided device data does not include information about available sizes or specific models of the Softip Catheter. For detailed specifications regarding sizes and models, please consult the manufacturer's product catalog or contact Angiomedics, Inc. for complete product information.