Safe Maxi Venous/Cardiotomy Reservoir, Model 016045

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

Full name

Safe Maxi Venous/Cardiotomy Reservior, Model 016045

510(k) Number

K022281 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Safe Mini

  Class II

  FDA 510(k) K980974 Active Cleared 13 Oct 2000

• Safe Maxi Hollow Fiber Oxygenator, Model 016010

  Class II

  FDA 510(k) K013038 Active Cleared 14 Aug 2002

• Safe II

  Class II

  FDA 510(k) K912082 Active Cleared 4 Dec 1991

• Safe Micro

  Class II

  FDA 510(k) K953976 Active Cleared 4 Feb 1997

• Pediatric Arterial Cannula

  Class II

  FDA 510(k) K023251 Active Cleared 4 Dec 2002

• What is the Safe Maxi Venous/Cardiotomy Reservoir used for?

  The Safe Maxi Venous/Cardiotomy Reservoir is designed for use with an oxygenator in an extracorporeal circuit. It stores venous return blood and defoams and filters intra-thoracic suction blood prior to returning it to the extracorporeal circuit during cardiovascular procedures.

• Is the Safe Maxi Venous/Cardiotomy Reservoir single-use or reusable?

  The Safe Maxi Venous/Cardiotomy Reservoir is supplied as a single-use product. It is not designed for reuse and should be discarded after a single procedure to ensure patient safety and device performance.

• What is the regulatory classification of the Safe Maxi Venous/Cardiotomy Reservoir?

  The Safe Maxi Venous/Cardiotomy Reservoir is classified as FDA Class 2 with Traditional clearance. It is regulated under product code DTN and regulation number 870.4400, with FDA clearance received on August 6, 2002.

• Who manufactures the Safe Maxi Venous/Cardiotomy Reservoir?

  The Safe Maxi Venous/Cardiotomy Reservoir is manufactured by Polystan A/S, located in Vaerlose, Denmark. The company specializes in medical devices for cardiovascular procedures and has been producing this device since receiving FDA clearance in 2002.