Scimed Membrane Oxygenator, Model 0600-2A

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

510(k) Number

K883053 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What types of medical procedures is the Scimed Membrane Oxygenator, Model 0600-2A, specifically designed to support during extracorporeal circulation?

  The Scimed Membrane Oxygenator, Model 0600-2A, is designed to facilitate gas exchange during critical cardiac and vascular procedures that require extracorporeal circulation. This includes surgeries like open-heart procedures, heart transplants, and other complex interventions where blood must be temporarily diverted outside the body to be oxygenated and carbon dioxide removed.

• Is the Scimed Membrane Oxygenator, Model 0600-2A, intended for reuse in clinical settings, or is it meant to be used only once?

  The Scimed Membrane Oxygenator, Model 0600-2A, is explicitly intended for single-use only in controlled clinical settings such as operating rooms or cardiac catheterization labs. This design ensures sterility and safety for each procedure, as reuse is not authorized or recommended.

• How should the Scimed Membrane Oxygenator, Model 0600-2A, be stored to maintain its integrity before use?

  Since the device is intended for sterile handling and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. The packaging must remain intact until immediately before use to preserve sterility and functionality.

• What regulatory pathway was followed for the FDA clearance of the Scimed Membrane Oxygenator, Model 0600-2A, and what class does it fall under?

  The Scimed Membrane Oxygenator, Model 0600-2A, was cleared through the FDA 510(k) pathway under the classification of a Class II medical device (regulation number 870.4350). The clearance was granted as substantially equivalent to a predicate device, following a traditional review process by the FDA’s Cardiovascular (CV) advisory committee.