Cpb Check Valve, Retrograde Flow, In-line
Cardiovascular · 21 CFR 870.4400
Recent MDR events
23 adverse event reports on file
- RETROGUARD ARTERIAL SAFETY VALVEJul 12, 2019MalfunctionQuest Medical, Inc1649914-2019-00032
- RETROGUARD ARTERIAL SAFETY VALVEDec 27, 2018MalfunctionQuest Medical, Inc1649914-2018-00100
- RETROGUARD ARTERIAL SAFETY VALVEMay 23, 2018MalfunctionQuest Medical, Inc1649914-2018-00046
- RETROGUARD ARTERIAL SAFETY VALVEMay 4, 2018MalfunctionQuest Medical, Inc1649914-2018-00044
- RETROGUARD ARTERIAL SAFETY VALVEFeb 24, 2018MalfunctionQuest Medical, Inc1649914-2018-00023
- RETROGUARD ARTERIAL SAFETY VALVEDec 13, 2017MalfunctionQuest Medical, Inc1649914-2017-00109
- RETROGUARD ARTERIAL SAFETY VALVEDec 8, 2017MalfunctionQuest Medical, Inc1649914-2017-00102
- RETROGUARD ARTERIAL SAFETY VALVENov 28, 2017MalfunctionQuest Medical, Inc1649914-2017-00100
- RETROGUARD ARTERIAL SAFETY VALVEFeb 16, 2016MalfunctionQuest Medical, Inc.1649914-2016-00003
- RETROGUARD ARTERIAL SAFETY VALVENov 20, 2015MalfunctionQuest Medical, Inc.1649914-2015-00099
Event type breakdown
Recalls
36 recall events for this product code
- Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV OA
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3222-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3223-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, Rev OA
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3224-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, Rev O
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3225-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3226-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV..1
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3227-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV.2, REV. 3
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3228-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV.3, REV. 5
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3229-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV.OB
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3230-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorpTerminatedSep 16, 2011
Cardiovascular Custom Procedure Kits, REV.4, REV. 5
3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
Z-3231-2011 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Quest Medical, Inc.Nov 6, 2018
K182442 · MiniGuard Arterial Safety Valve
- Terumo Cardiovascular Systems CorporationJan 29, 2015
K142500 · One Way Soft Valve
- 3t Medical Systems, LLCAug 15, 2001
K001245 · 3T L. V. CONTROL VALVE
- International Biophysics Corp.Jan 14, 2000
K992785 · IBC FLOGUARD, MODEL 6050
- Cobe Cardiovascular, Inc.Oct 7, 1998
K982406 · COBE VACUUM RELIEF CHECK VALVE
- R D Intl.Jun 5, 1996
K960937 · SUCTION SAFETY DEVICE
- American Omni Medical, Inc.Mar 8, 1993
K922781 · FLOW CONROL VALVE
- American Omni Medical, Inc.Feb 12, 1993
K922356 · FLOW CONTROL VALVE, CAT. NO. ACV-38