510(k) K915183 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
SARNS 8000 MODULAR PERFUSION SYSTEM
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jul 8, 1992 |
| Received | Nov 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2012 | Terumo 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 |
DTQ | None listed |
| Nov 13, 2012 | Terumo 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 |
DTQ | None listed |
| Nov 13, 2012 | Terumo 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 |
DTQ | None listed |
| Nov 13, 2012 | Terumo 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 |
DTQ | None listed |
| Nov 13, 2012 | Terumo 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 |
DTQ | None listed |
| Nov 13, 2012 | Terumo 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 |
DTQ | None listed |
| Oct 24, 2012 | Terumo 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 |
DTQ | None listed |
| Oct 24, 2012 | Terumo 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 |
DTQ | None listed |
| Oct 24, 2012 | Terumo 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 |
DTQ | None listed |
| Oct 24, 2012 | Terumo 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 |
DTQ | None listed |
| Oct 24, 2012 | Terumo 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 |
DTQ | None listed |
| Oct 24, 2012 | Terumo 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 |
DTQ | None listed |
| Sep 11, 2012 | Terumo 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 |
DTQ | None listed |
| Aug 16, 2012 | Terumo 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 |
DTQ | None listed |
| Jul 19, 2012 | Terumo 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 |
DTQ | None listed |
| Jul 19, 2012 | Terumo 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 |
DTQ | None listed |
| Jul 19, 2012 | Terumo 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 |
DTQ | None listed |
| Jul 19, 2012 | Terumo 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 |
DTQ | None listed |
| Jul 19, 2012 | Terumo 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 |
DTQ | None listed |
| Jul 19, 2012 | Terumo 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 |
DTQ | None listed |
| Apr 23, 2012 | Terumo 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 |
DTQ | None listed |
| Apr 23, 2012 | Terumo 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 |
DTQ | None listed |
| Apr 23, 2012 | Terumo 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 |
DTQ | None listed |
| Apr 23, 2012 | Terumo 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 |
DTQ | None listed |
| Nov 29, 2011 | Terumo 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 |
DWB | 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 |
| Dec 8, 2010 | Terumo 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 |
JOR | None listed |
| Dec 8, 2010 | Terumo 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 |
JOR | None listed |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. Terminated |
DTQ | None listed |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407. Terminated |
DTQ | None listed |
| Jul 7, 2007 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395. Terminated |
DTQ | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409. Terminated |
DTW | None listed |
| Dec 7, 2006 | Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. Terminated |
DTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.