Versa-Cath Arterial Catheter

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

510(k) Number

K961883 ↗

FDA Product Code

DXE

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pruitt Safety Occlusion Catheter

  Class II

  FDA 510(k) K960422 Active Cleared 7 Aug 1996

• Godat Uterine Manipulator Injector

  Class II

  FDA 510(k) K935023 Active Cleared 4 Jan 1995

• Pruitt Embolectomy/Irrigation Catheter (Modified)

  Class II

  FDA 510(k) K864062 Active Cleared 6 Jan 1987

• Modified Pruitt Irrigation & Occlusion Catheter Open recall

  Class II

  FDA 510(k) K880231 Active Cleared 25 May 1988

• Ideas Dual Port

  Class II

  FDA 510(k) K962751 Active Cleared 30 Sep 1996

• Robicsek–Pruitt Aortic Balloon Occlusion Kit

  Class II

  FDA 510(k) K872090 Active Cleared 30 Oct 1987

See all devices from Ideas For Medicine, Inc. →

• What is the primary clinical use of the Versa-Cath Arterial Catheter?

  The Versa-Cath Arterial Catheter is specifically designed for use in cardiovascular procedures as an embolectomy catheter to assist in the removal of emboli.

• Can this catheter be used with a guidewire?

  Yes, the device is engineered to support catheter placement over a guidewire, which allows for precise navigation during cardiovascular interventions.

• What is the regulatory status of this device?

  The Versa-Cath Arterial Catheter is a Class II medical device that has received FDA 510(k) clearance under reference number K961883.