Posterior Annuloplasty Band (Model 607)

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

510(k) Number

K960356 ↗

FDA Product Code

KRH

Device Class

Class II

Regulation

21 CFR Part 870.3800

Advisory Committee

Cardiovascular

FDA Decision

ST

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• What is the primary purpose of the Posterior Annuloplasty Band (Model 607) in mitral valve surgery?

  The Posterior Annuloplasty Band (Model 607) is designed to provide structural reinforcement to the posterior leaflet of the mitral valve. By supporting and stabilizing the mitral valve annulus, it helps restore the annular geometry, which improves overall valve function and reduces the risk of mitral regurgitation during surgical repair.

• Is the Posterior Annuloplasty Band (Model 607) intended for reuse, or is it meant to be used only once?

  The Posterior Annuloplasty Band (Model 607) is explicitly supplied as a single-use device. This ensures sterility and safety for each patient, as it is intended to be implanted during surgery without subsequent reuse.

• How is the Posterior Annuloplasty Band (Model 607) made visible during imaging, and what material is it constructed from?

  The band is constructed from a pliable silicone elastomer strip covered in polyester fabric, which provides flexibility and durability. To ensure visibility under X-ray or fluoroscopy, it is impregnated with barium sulfate, a radiopaque substance that enhances imaging clarity during surgical procedures.

• What regulatory pathway was followed for FDA clearance of the Posterior Annuloplasty Band (Model 607), and how is it classified?

  The device received FDA clearance under the Traditional review pathway and is classified as a Class II medical device. It is tracked under registration number 2015691 and falls under the product code KRH, which categorizes it within cardiovascular surgical annuloplasty devices.