Cooley 2 Vascular Prosthesis Straight

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

510(k) Number

K812248 ↗

FDA Product Code

DSY

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiac Electrode K760443

  Class III

  FDA 510(k) K760443 Active Cleared 26 Aug 1976

• Meadox Exxcel Eptfe Vascular Graft

  Class II

  FDA 510(k) K962433 Active Cleared 17 Mar 1997

• Ms Classique Balloon Catheter

  Class II

  FDA 510(k) K942293 Active Cleared 18 Oct 1994

• Meadox(R) Surgimed Olbert Catheter System(R)

  Class II

  FDA 510(k) K921706 Active Cleared 20 May 1993

• Naviguide Hydrophilic Guide Wire

  Class II

  FDA 510(k) K943358 Active Cleared 2 Jun 1995

• Hemashield Microvel Velour Knitted Vascular Graft

  Class II

  FDA 510(k) K954848 Active Cleared 1 Feb 1996

See all devices from Meadox Medicals, Div. Boston Scientific Corp. →

• What types of cardiovascular procedures is the Cooley 2 Vascular Prosthesis Straight intended for, and how is it used in those procedures?

  The Cooley 2 Vascular Prosthesis Straight is designed for surgical implantation to replace or bypass damaged blood vessels with a diameter of 6mm or greater. It is intended for use in vascular reconstruction procedures, such as bypass surgeries or direct vessel replacements, where a durable synthetic graft is required to restore blood flow. The prosthesis is sewn into place during surgery to create a new pathway for blood circulation, ensuring continuity where natural vessels are compromised.

• Is the Cooley 2 Vascular Prosthesis Straight intended for reuse, or is it meant to be used only once?

  The Cooley 2 Vascular Prosthesis Straight is explicitly intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in surgical settings where infection control is paramount.

• How is the Cooley 2 Vascular Prosthesis Straight supplied, and what should I consider when storing it?

  The device is supplied sterile, ready for immediate use in controlled surgical environments. Since it is single-use, it should be stored in its original packaging in a clean, dry place away from direct sunlight or extreme temperatures. Proper storage ensures the graft remains uncontaminated and maintains its structural integrity until use.

• What regulatory pathway does the Cooley 2 Vascular Prosthesis Straight follow, and how does this affect its use?

  The Cooley 2 Vascular Prosthesis Straight is regulated under the FDA’s 510(k) clearance process, specifically classified as a Prosthesis, Vascular Graft, of 6mm and greater diameter. It was granted clearance in 1981 under the traditional review pathway and is categorized under the Cardiovascular Device classification. This means it has undergone FDA evaluation to ensure safety and effectiveness for its intended surgical use in vascular reconstruction.