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510(k) K073559

Device
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
510(k) number
K073559
Product code
DQR  
Decision
Substantially Equivalent (SESE)
Decision date
2008-01-31
Date received
2007-12-19
Regulation
870.1300
Classification name
Cannula, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN W NICHOLSON
Address
6864 S. 300 W. Midvale UT US 84047 84047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131446INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESIntegra LifeSciences Corporation2013-10-28
K051655ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.2005-09-12
K030398CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221Cardiacassist, Inc.2003-05-23
K960098RMI INTERNAL MAMMARY ARTERY CANNULAResearch Medical, Inc.1996-03-26
K902674DATASCOPE ARTERIAL CANNULA W/ACCESS PORTDatascope Corp.1991-01-16
K894784MODIFIED SHILEY FEMORAL VENOUS CANNULAShiley, Inc.1990-03-28
K894243RMI ARTERIAL PERFUSION CANNULAResearch Medical, Inc.1989-09-19
K884628HARBORIN CENTRAL VENOUS CATHETERHarbor Medical Devices, Inc.1989-05-15
K884478DAIG COLLAPSIBLE STERILE SLEEVEDaig Corp.1989-02-22
K884375TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETERArgon Medical Corp.1989-01-11
K882977ASK-300Medical Repackers Co.1989-01-05
K881884HARBOR CENTRAL VENOUS CATHETERHarbor Medical Devices, Inc.1988-07-28
K880771MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEMMedsurg Industries, Inc.1988-05-03
K873012INFANT CANNULAGresco International, Inc.1988-05-02
K8807767 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEMMedsurg Industries, Inc.1988-05-02

Legacy Summary#

summary

FDA Review#

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