Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir, Cvr 600 and 1200 Softshe

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K990103 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K942582 Active Cleared 27 Jan 1995

• Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy Reservoir with Filt

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  FDA 510(k) K964907 Active Cleared 21 Aug 1997

• Code 150 Blood Component Collection Set and with Direct Draw Line

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  FDA 510(k) K963758 Active Cleared 20 Feb 1998

• Dideco Pediatric Arterial Filters

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  FDA 510(k) K945198 Active Cleared 27 Jun 1995

• Sorin Monolyth Venous Reservoir

  Class II

  FDA 510(k) K933481 Active Cleared 2 Nov 1993

• Sorin Bcd Advanced Pediatric Blood Cardioplegia Systems

  Class II

  FDA 510(k) K936183 Active Cleared 23 Mar 1994

See all devices from Sorin Biomedical, Inc. →