Atlas FDA

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK

FDA 510(k) clearance K881330 · decided 1988-06-10

Clearance details

K-number
K881330
Device name
COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
Applicant
Cobe Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1988-03-29
Decision date
1988-06-10
Days to decision
73 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lakewood, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusio recall (Z-1985-2013)Sorin Group USA, Inc.2013-08-20
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Gro recall (Z-0370-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400, Manufactured by Sorin Gro recall (Z-0371-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500, Manufactured by Sorin Gro recall (Z-0372-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Gro recall (Z-0373-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Gro recall (Z-0374-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300, Manufactured by Sorin Gro recall (Z-0375-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Gro recall (Z-0376-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Gro recall (Z-0377-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500600, Manufactured by Sorin Gro recall (Z-0378-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500700, Manufactured by Sorin Gro recall (Z-0379-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Gro recall (Z-0380-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900, Manufactured by Sorin Gro recall (Z-0381-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001, Manufactured by Sorin Gro recall (Z-0382-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501200, Manufactured by Sorin Gro recall (Z-0383-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502000, Manufactured by Sorin Gro recall (Z-0384-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502100, Manufactured by Sorin Gro recall (Z-0385-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by Sorin Gro recall (Z-0386-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503400, Manufactured by Sorin Gro recall (Z-0387-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503500, Manufactured by Sorin Gro recall (Z-0388-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300, Manufactured by Sorin Gro recall (Z-0389-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500, Manufactured by Sorin Gro recall (Z-0390-2011)Sorin Group USA, Inc.2010-11-15
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin Gro recall (Z-0391-2011)Sorin Group USA, Inc.2010-11-15
Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W recall (Z-1084-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1085-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1086-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1087-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1088-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1089-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1090-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1091-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1092-2010)Sorin Group USA, Inc.2010-03-12
Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arva recall (Z-1093-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1094-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1095-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1096-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1097-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1098-2010)Sorin Group USA, Inc.2010-03-12
, REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 I recall (Z-1099-2010)Sorin Group USA, Inc.2010-03-12