Cobe Sentry SmarXT 43 Micron Arterial Filter With PrimeGard

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

510(k) Number

K982254 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cobe Brat 2 Autologous Blood Salvage System With Crit-Line Hematocrit Sampling System

  Class II

  FDA 510(k) K991986 Active Cleared 9 Sep 1999

• Heat Exchanger Modification for Duo and Optima

  Class II

  FDA 510(k) K944267 Active Cleared 28 Apr 1995

• Cobe Patient Monitoring Products

  Class II

  FDA 510(k) K921343 Active Cleared 5 Jan 1993

• Cobe Sampling Site

  Class II

  FDA 510(k) K922484 Active Cleared 3 Dec 1992

• Cobe Cms-Fs Membrane Oxygenator

  Class II

  FDA 510(k) K926467 Active Cleared 9 Nov 1993

• Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator

  Class II

  FDA 510(k) K000255 Active Cleared 25 Apr 2000

See all devices from Cobe Cardiovascular, Inc. →

• What is the primary purpose of the Cobe Sentry SmarXT 43µ Arterial Filter With PrimeGard?

  This filter is designed to remove particulate matter and emboli from blood during cardiopulmonary bypass procedures. By integrating into the arterial line of an extracorporeal circuit, it helps protect the patient’s circulatory system from debris that could otherwise cause complications. The 43-micron pore size balances effective filtration with maintaining adequate blood flow.

• How is the Cobe Sentry SmarXT 43µ Arterial Filter With PrimeGard supplied and prepared for use?

  The filter is supplied as a single-use, sterile component, intended exclusively for controlled clinical settings like operating rooms or cardiac catheterization labs. It comes pre-packaged and ready for immediate use, eliminating the need for additional sterilization. Always verify the expiration date on the packaging before use to ensure sterility and performance.

• Does the PrimeGard coating on this filter provide any additional benefits?

  Yes, the PrimeGard coating is a proprietary antimicrobial barrier that enhances sterility and reduces the risk of contamination during use. This coating helps maintain a cleaner environment within the filter, lowering the potential for microbial growth that could compromise patient safety during cardiopulmonary bypass procedures.

• Can the Cobe Sentry SmarXT 43µ Arterial Filter With PrimeGard be reused?

  No, this filter is designed for single-use only. Reusing it could compromise sterility, increase the risk of contamination, and reduce its effectiveness in filtering emboli. Always adhere to the manufacturer’s instructions for proper disposal after a single use to ensure patient safety and regulatory compliance.

• What storage conditions are required for the Cobe Sentry SmarXT 43µ Arterial Filter With PrimeGard?

  The filter must be stored in a dry environment, protected from moisture and extreme temperatures. Exposure to humidity or temperature fluctuations could degrade the PrimeGard coating or compromise the filter’s structural integrity. Always store it in its original packaging until ready for use and discard it if the expiration date has passed.