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CABG Rings

by A&A Ent. 510(k)

Active United States

510(k) K771819

Overview

The CABG Rings are a type of Prosthesis, Vascular Graft, designed for diameters of 6mm and greater. These devices are intended for use in coronary artery bypass grafting (CABG) procedures, providing structural support and patency to the grafted vessel.

Supplied as a sterile, single-use device, the CABG Rings are regulated under FDA 510(k) clearance (K771819) and fall under device classification DSY. They are intended for use in controlled surgical environments and must be handled according to standard aseptic techniques. The product is authorized for cardiovascular applications and adheres to regulatory requirements outlined in 870.3450.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771819 Date21 Oct 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSY
Device Class
Class II
Regulation
21 CFR Part 870.3450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from A&A Ent.

  • Vein Clamps

    Class II

Questions

  • What is the CABG Rings device used for in surgical procedures?

    The CABG Rings are designed specifically for coronary artery bypass grafting (CABG) procedures. They provide structural support and help maintain patency (open flow) of the grafted vessel, ensuring long-term success of the bypass. This is particularly important for larger vessels with diameters of 6mm or greater, where stability and durability are critical.

  • Are the CABG Rings intended for single-use or reuse?

    The CABG Rings are supplied as a sterile, single-use device. This design ensures patient safety by preventing cross-contamination and maintaining sterility between procedures. Single-use also aligns with best practices for surgical implants, reducing the risk of infection and ensuring consistent performance.

  • What diameters of vessels are compatible with the CABG Rings?

    These rings are engineered for use in vessels with diameters of 6mm and greater. The sizing is tailored to accommodate larger coronary arteries commonly involved in CABG procedures, providing optimal support and minimizing the risk of graft collapse or occlusion over time.

  • How should the CABG Rings be stored to maintain sterility?

    The CABG Rings must be stored according to standard aseptic techniques to preserve sterility. They should be kept in their original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the device remains uncontaminated and ready for use in controlled surgical settings.

  • What regulatory pathway does the CABG Rings follow?

    The CABG Rings are regulated under the FDA’s 510(k) clearance pathway, specifically classified under product code DSY (Prosthesis, Vascular Graft, of 6mm and Greater Diameter). The device was granted clearance under the traditional 510(k) process with a decision code of SESE (Substantially Equivalent), indicating it meets FDA requirements for safety and effectiveness compared to predicate devices.