Medical Device Manufacturer · US , Irvine , CA

Sorin Biomedical, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1993

Total

Cleared

Denied

Sorin Biomedical, Inc. has 15 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.

Historical record: 15 cleared submissions from 1993 to 1999.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Sorin Biomedical, Inc.

15 devices

1-12 of 15

Cleared Nov 05, 1999

MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL...

K990103 · DTZ

Cardiovascular · 297d

Cleared Feb 20, 1998

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

K963758 · CAC

Anesthesiology · 520d

Cleared Feb 20, 1998

DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

K963759 · CAC

Anesthesiology · 520d

Cleared Sep 03, 1997

VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER

K964908 · DTN

Cardiovascular · 268d

Cleared Aug 21, 1997

VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY...

K964907 · DTN

Cardiovascular · 255d

Cleared Aug 12, 1996

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

K961869 · DTM

Cardiovascular · 89d

Cleared Aug 21, 1995

DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON...

K952270 · DTM

Cardiovascular · 98d

Cleared Jun 27, 1995

DIDECO PEDIATRIC ARTERIAL FILTERS

K945198 · DTM

Cardiovascular · 246d

Cleared May 19, 1995

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063

K945065 · DTN

Cardiovascular · 217d

Cleared May 10, 1995

VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR

K941215 · DTN

Cardiovascular · 426d

Cleared Jan 27, 1995

SORIN BLOOD CARDIOPLEGIA CONSOLE

K942582 · DTQ

Cardiovascular · 240d

Cleared Apr 15, 1994

SORIN BLOOD CARDIOPLEGIA SYSTEM

K934763 · DTN

Cardiovascular · 192d

Sorin Biomedical, Inc. - FDA 510(k) Cleared Devices

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