Intersept 40 Micron Filter W/Tubing

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

510(k) Number

K833476 ↗

FDA Product Code

DTM

Device Class

Class II

Regulation

21 CFR Part 870.4260

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Male Luer Connector & Hinged Cap

  Class II

  FDA 510(k) K820169 Active Cleared 5 Feb 1982

• Parallel Plate Dialyzer Holder

  Class II

  FDA 510(k) K811292 Active Cleared 2 Jun 1981

• Tracheostomy Tubes, Short and Long Term

  Class II

  FDA 510(k) K791044 Active Cleared 13 Jun 1979

• Ultrafiltration Controller

  Class II

  FDA 510(k) K832547 Active Cleared 3 Jan 1984

• Extracorporeals' Alternate Membrane

  Class II

  FDA 510(k) K801344 Active Cleared 21 Jul 1980

• Intersept* Venous Reservoir Bag & Holder

  Class II

  FDA 510(k) K803059 Active Cleared 22 Dec 1980

See all devices from Extracorporeal Medical Specialities, Inc. →

• What is the Intersept 40 Micron Filter W/Tubing used for?

  The Intersept 40 Micron Filter W/Tubing is designed for blood filtration during cardiopulmonary bypass arterial line use in cardiovascular procedures. It helps remove particulate matter from blood during these medical interventions.

• Is the Intersept 40 Micron Filter W/Tubing single-use or reusable?

  The Intersept 40 Micron Filter W/Tubing is intended for single use only. It should not be reused or resterilized as this could compromise its filtering effectiveness and patient safety.

• What regulatory approvals does the Intersept 40 Micron Filter W/Tubing have?

  The Intersept 40 Micron Filter W/Tubing has FDA 510(k) clearance with K number K833476, granted on December 27, 1983. It is classified as a Class 2 medical device for cardiovascular procedures.

• How is the Intersept 40 Micron Filter W/Tubing supplied?

  The device is supplied with tubing included, making it ready for immediate use in cardiopulmonary bypass procedures. It comes as a complete unit with the filter and connected tubing for arterial line filtration.