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510(k) K884628

Device
HARBORIN CENTRAL VENOUS CATHETER
Applicant
HARBOR MEDICAL DEVICES, INC.
510(k) number
K884628
Product code
DQR  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-15
Date received
1988-11-07
Regulation
870.1300
Classification name
Cannula, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOSHUA TOLKOFF
Address
25 Drydock Ave. Boston MA US 02210 02210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research Medical2008-01-31
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
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#

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FDA Review#

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