ClearanceBrief
510(k) K915183 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

SARNS 8000 MODULAR PERFUSION SYSTEM

Applicant3M Health Care, Sarns, Ann Arbor MI, US
DecisionSubstantially Equivalent, Jul 8, 1992
ReceivedNov 18, 1991
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K915183

DateFirm and productCodeLinked 510(k)
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQNone listed
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQNone listed
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for ar
Terminated
DTQNone listed
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for ar
Terminated
DTQNone listed
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQNone listed
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQNone listed
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQNone listed
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQNone listed
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for art
Terminated
DTQNone listed
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for art
Terminated
DTQNone listed
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQNone listed
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQNone listed
Sep 11, 2012Terumo Cardiovascular Systems Corporation
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, region
Terminated
DTQNone listed
Aug 16, 2012Terumo Cardiovascular Systems Corporation
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, a
Terminated
DTQNone listed
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion
Terminated
DTQNone listed
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusio
Terminated
DTQNone listed
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfu
Terminated
DTQNone listed
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfu
Terminated
DTQNone listed
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion
Terminated
DTQNone listed
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQNone listed
Apr 23, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and thr
Terminated
DTQNone listed
Apr 23, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three
Terminated
DTQNone listed
Apr 23, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8
Terminated
DTQNone listed
Apr 23, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000
Terminated
DTQNone listed
Nov 29, 2011Terumo Cardiovascular Systems Corporation
Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial
Terminated
DWBNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pack, Sterile, Terumo Cardiovascular Systems Ashland, MA. The pressure monitoring kit is indicated for sterile
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung Pack, Sterile, Terumo Cardiovascular Systems Ashland, MA. The pressure monitoring kit is indicated for sterile si
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated Low Prime Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicate
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System 1 Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for st
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit, Part number 65418-01, Terumo Latin America Seminsa Pediatric Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for steril
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit, Part number 65672-01, Terumo Latin America Seminsa lactante, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile sing
Terminated
DTQNone listed
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit, Part number 65871, Terumo Latin America Lactante Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile singl
Terminated
DTQNone listed
Dec 8, 2010Terumo Cardiovascular Systems Corporation
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. The system 8000 is indicated for use in extracorpor
Terminated
JORNone listed
Dec 8, 2010Terumo Cardiovascular Systems Corporation
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) The system 8000 is indic
Terminated
JORNone listed
Jul 7, 2007Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402.
Terminated
DTQNone listed
Jul 7, 2007Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407.
Terminated
DTQNone listed
Jul 7, 2007Terumo Cardiovascular Systems Corp
Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395.
Terminated
DTQNone listed
Dec 7, 2006Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
Terminated
DTWNone listed
Dec 7, 2006Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
Terminated
DTWNone listed
Dec 7, 2006Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
Terminated
DTWNone listed
Dec 7, 2006Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406.
Terminated
DTWNone listed
Dec 7, 2006Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409.
Terminated
DTWNone listed
Dec 7, 2006Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
Terminated
DTWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.