Atlas FDA

ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH

FDA 510(k) clearance K022947 · decided 2003-03-20

Clearance details

K-number
K022947
Device name
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
Applicant
Terumo Cardiovascular Systems Corp.
Decision
Substantially Equivalent
Date received
2002-09-05
Decision date
2003-03-20
Days to decision
196 days
Clearance type
Traditional
Product code
DTQ
Device class
2
Regulation number
870.4220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System recall (Z-1687-2015)Terumo Cardiovascular Systems Corporation2015-05-28
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo Advanced Perfusion System recall (Z-1688-2015)Terumo Cardiovascular Systems Corporation2015-05-28
Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS) recall (Z-2018-2014)Terumo Cardiovascular Systems Corporation2014-07-08
Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS) recall (Z-2019-2014)Terumo Cardiovascular Systems Corporation2014-07-08
100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion Syst recall (Z-1977-2013)Terumo Cardiovascular Systems Corporation2013-08-15
220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo Advanced Perfusion Syst recall (Z-1978-2013)Terumo Cardiovascular Systems Corporation2013-08-15
Terumo Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo Ad recall (Z-1968-2013)Terumo Cardiovascular Systems Corporation2013-08-14
Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Ad recall (Z-1969-2013)Terumo Cardiovascular Systems Corporation2013-08-14
Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo recall (Z-1973-2013)Terumo Cardiovascular Systems Corporation2013-08-14
Terumo Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage recall (Z-1974-2013)Terumo Cardiovascular Systems Corporation2013-08-14
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System recall (Z-0435-2013)Terumo Cardiovascular Systems Corporation2012-11-27
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System recall (Z-0436-2013)Terumo Cardiovascular Systems Corporation2012-11-27
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circula recall (Z-2449-2012)Terumo Cardiovascular Systems Corporation2012-09-25
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Pe recall (Z-2443-2012)Terumo Cardiovascular Systems Corporation2012-09-24
Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data tr recall (Z-2230-2012)Terumo Cardiovascular Systems Corporation2012-08-21
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data tr recall (Z-2231-2012)Terumo Cardiovascular Systems Corporation2012-08-21
Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is recall (Z-2232-2012)Terumo Cardiovascular Systems Corporation2012-08-21
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the recall (Z-2233-2012)Terumo Cardiovascular Systems Corporation2012-08-21
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extr recall (Z-2177-2012)Terumo Cardiovascular Systems Corporation2012-08-09
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extr recall (Z-2178-2012)Terumo Cardiovascular Systems Corporation2012-08-09
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-2055-2012)Terumo Cardiovascular Systems Corporation2012-07-20
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-2056-2012)Terumo Cardiovascular Systems Corporation2012-07-20
Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion recall (Z-2042-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion recall (Z-2043-2012)Terumo Cardiovascular Systems Corporation2012-07-19
System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for u recall (Z-2020-2012)Terumo Cardiovascular Systems Corporation2012-07-17
System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for u recall (Z-2021-2012)Terumo Cardiovascular Systems Corporation2012-07-17
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion recall (Z-2009-2012)Terumo Cardiovascular Systems Corporation2012-07-13
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion recall (Z-2010-2012)Terumo Cardiovascular Systems Corporation2012-07-13
Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blen recall (Z-1962-2012)Terumo Cardiovascular Systems Corporation2012-07-09
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion recall (Z-1963-2012)Terumo Cardiovascular Systems Corporation2012-07-09
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion recall (Z-1964-2012)Terumo Cardiovascular Systems Corporation2012-07-09
System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-1965-2012)Terumo Cardiovascular Systems Corporation2012-07-09
System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-1966-2012)Terumo Cardiovascular Systems Corporation2012-07-09
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-1968-2012)Terumo Cardiovascular Systems Corporation2012-07-09
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-1969-2012)Terumo Cardiovascular Systems Corporation2012-07-09
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-1970-2012)Terumo Cardiovascular Systems Corporation2012-07-09
System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up recall (Z-1971-2012)Terumo Cardiovascular Systems Corporation2012-07-09
Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion recall (Z-1957-2012)Terumo Cardiovascular Systems Corporation2012-07-06
Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion recall (Z-1958-2012)Terumo Cardiovascular Systems Corporation2012-07-06
Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusi recall (Z-1320-2012)Terumo Cardiovascular Systems Corporation2012-03-27
Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusi recall (Z-1321-2012)Terumo Cardiovascular Systems Corporation2012-03-27
Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use f recall (Z-0839-2012)Terumo Cardiovascular Systems Corporation2012-01-24
Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use f recall (Z-0840-2012)Terumo Cardiovascular Systems Corporation2012-01-24
The Terumo Advanced Perfusion System 1, Catalog Number 801763, System 1 Base, 110 V Produc recall (Z-0298-2012)Terumo Cardiovascular Systems Corporation2011-11-29
The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product recall (Z-0299-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product Usag recall (Z-0300-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 Product Usage: The recall (Z-0301-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The recall (Z-0302-2012)Terumo Cardiovascular Systems Corporation2011-11-29
System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI Th recall (Z-2735-2011)Terumo Cardiovascular Systems Corporation2011-07-06
System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI Th recall (Z-2736-2011)Terumo Cardiovascular Systems Corporation2011-07-06