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510(k) K871131 · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

SARNS 9000 HEART-LUNG CONSOLE

Applicant	3M Health Care, Sarns, Ann Arbor MI, US
Decision	Substantially Equivalent, May 21, 1987
Received	Mar 20, 1987
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K871131

Date	Firm and product	Code	Linked 510(k)
Jul 19, 2012	Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, Terminated	DTQ	None listed
Jul 19, 2012	Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusi Terminated	DTQ	None listed
Jul 19, 2012	Terumo Cardiovascular Systems Corporation Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, Terminated	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Jun 22, 2011	Terumo 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	DTQ	None listed
Nov 7, 2008	Terumo Cardiovascular Systems Corporation Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Terminated	DTQ	None listed
Nov 7, 2008	Terumo Cardiovascular Systems Corporation Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Sy Terminated	DTQ	None listed

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