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510(k) K902444

Device
CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
Applicant
INTRAMED LABORATORIES, INC.
510(k) number
K902444
Product code
DQI  
Decision
Substantially Equivalent (SESE)
Decision date
1990-08-30
Date received
1990-06-01
Regulation
870.1800
Classification name
Withdrawal/infusion Pump
Medical specialty
Cardiovascular
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
A SOSNOWSKI
Address
11100 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960486KSEA MODEL 383320 20 ANGIOMATKarl Storz Endoscopy1996-10-25
K935763SURGIPUMPW.O.M. World of Medicine GmbH1994-04-21
K922541USCI SUPER 9 PTCA GUIDING CATHETERC.R. Bard, Inc.1992-12-08
K924110LEOCOR CORFLO PUMP -- MODIFICATIONLeocor, Inc.1992-09-01
K905189BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)Baxter Healthcare Corp1991-01-30
K895688NOBLES-LAI ENGINEERING INFUSION PUMPNobles-Lai Engineering, Inc.1990-02-26
K895074ANGIOSCOPY PUMPBaxter Healthcare Corp1990-01-31
K871422OLYMPUS ANGIOSCOPY PUMPOlympus Corp.1987-08-12

Legacy Summary#

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FDA Review#

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