3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System

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

510(k) Number

K950739 ↗

FDA Product Code

DWA

Device Class

Class II

Regulation

21 CFR Part 870.4380

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Monitor Kits, Blood Level

  Class II

  FDA 510(k) K781145 Active Cleared 27 Jul 1978

• Flexible Arterial Cannulae

  Class II

  FDA 510(k) K771499 Active Cleared 16 Aug 1977

• Battery Operated Flow Rate Computer

  Class II

  FDA 510(k) K760756 Active Cleared 15 Oct 1976

• Centrifugal Pump System Lx/Dx Version

  Class II

  FDA 510(k) K882758 Active Cleared 13 Oct 1988

• Clear Cardioplejia Delivery System

  Class II

  FDA 510(k) K823451 Active Cleared 14 Jan 1983

• Sarns Filtered Cardiotomy Reservoir

  Class II

  FDA 510(k) K860702 Active Cleared 28 May 1986

See all devices from 3M Health Care, Sarns →

• What is the 3M Sarns Flow Sensor, Centrifugal Control Module 115 used for?

  The 3M Sarns Flow Sensor, Centrifugal Control Module 115 is specifically designed to regulate pump speed in cardiopulmonary bypass procedures. This control module ensures precise flow control within the 900 Perfusion System, which is critical for maintaining stable circulation during cardiovascular surgeries.

• How is the Centrifugal Control Module 115 supplied and what are its key specifications?

  The device is supplied as part of the 900 Perfusion System and operates at 220 V. It is classified under product code DWA and falls under FDA regulation number 870.4380. The module is intended for use in cardiovascular applications, ensuring accurate pump speed regulation during cardiopulmonary bypass.

• Is the 3M Sarns Flow Sensor, Centrifugal Control Module 115 single-use or reusable?

  The provided data does not explicitly state whether the device is single-use or reusable. However, given its role as a control module in a perfusion system—where sterility and precision are critical—it is likely intended for single-use to maintain patient safety and regulatory compliance. Always verify with manufacturer guidelines before use.

• What regulatory clearance does the Centrifugal Control Module 115 hold?

  The device holds FDA 510K clearance under the reference number K950739, with a decision date of November 17, 1995. It was determined to be substantially equivalent to a predicate device and falls under the Cardiovascular (CV) advisory committee. The clearance confirms its compliance with U.S. regulatory standards for Class II medical devices.

• How should the Centrifugal Control Module 115 be stored?

  While specific storage instructions are not detailed in the provided data, general best practices for perfusion system components—especially those intended for sterile use—include storing in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure packaging remains intact until immediate use to prevent contamination. Always follow the manufacturer’s instructions for optimal performance and sterility.