Silent Guard Cat. No. Sg-10

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

510(k) Number

K873488 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Flow Control Valve, Cat. No. Acv-38

  Class II

  FDA 510(k) K922356 Active Cleared 12 Feb 1993

• Cardiotomy Reservoir Valve No. Crv-30 or Pcrv-25

  Class I

  FDA 510(k) K884893 Active Cleared 30 Jan 1989

• Air Vent Line Cat. No. Avl-36

  Class II

  FDA 510(k) K875080 Active Cleared 29 Feb 1988

• Prebypass Filter

  Class II

  FDA 510(k) K871350 Active Cleared 8 Jun 1987

• Modified Rlv-2100 B

  Class II

  FDA 510(k) K864503 Active Cleared 6 Jan 1987

• Exu-Bag Csu-1200(Dispos)Canister 602-2(Non-Dispos

  Class II

  FDA 510(k) K852178 Active Cleared 27 Dec 1985

See all devices from American Omni Medical, Inc. →

• What is the Silent Guard SG-10 adaptor used for?

  The Silent Guard SG-10 is a cardiopulmonary bypass adaptor designed to control fluid flow and pressure within extracorporeal circuits during cardiovascular procedures. It ensures precise management of oxygenated blood, helping maintain circuit integrity and minimizing risks of air embolism during bypass operations.

• Is the Silent Guard SG-10 adaptor single-use or reusable?

  The Silent Guard SG-10 is supplied as a reusable medical instrument. It is intended for use in sterile environments like cardiac catheterization labs or surgical theaters, where it can be cleaned and reused according to established protocols.

• What regulatory clearance does the Silent Guard SG-10 adaptor have?

  The Silent Guard SG-10 adaptor holds FDA 510(k) clearance under the Cardiovascular advisory committee classification, with a decision code of SESE (Substantially Equivalent). This clearance confirms its compliance with U.S. regulatory standards for use in cardiopulmonary bypass procedures.

• Can the Silent Guard SG-10 adaptor be used with MRI equipment?

  The provided regulatory data does not specify MRI safety for the Silent Guard SG-10 adaptor. Clinicians should verify compatibility with their MRI systems before use to ensure patient safety.

• What types of cardiovascular procedures is the Silent Guard SG-10 adaptor compatible with?

  The Silent Guard SG-10 adaptor is designed for integration into perfusion systems used during cardiopulmonary bypass procedures. It is compatible with related cardiovascular devices and is intended to support controlled fluid management in sterile operating environments, such as cardiac surgeries.