510(k) K881330 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
| Applicant | Cobe Laboratories, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Jun 10, 1988 |
| Received | Mar 29, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2018 | LivaNova USA Perfusion Pack, Rx only, Sterile EO Terminated |
DWF | None listed |
| Jan 19, 2016 | Sorin Group USA, Inc. CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack.
Product Usage:
Heart/Lung Perfusion Pack is either a customized tubing pack built Terminated |
DWF | None listed |
| Aug 20, 2013 | Sorin Group USA, Inc. Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500600, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500700, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501200, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502000, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502100, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503400, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Nov 15, 2010 | Sorin Group USA, Inc. Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorpo Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for p Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of up to Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of Terminated |
DWF | None listed |
| Mar 12, 2010 | Sorin Group USA, Inc. , REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.