FDA.reportPublic FDA data

510(k) K014016

Device
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
Applicant
Minntech Corp.
510(k) number
K014016
Product code
DWC
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-01
Date received
2001-12-05
Regulation
870.4250
Classification name
Controller, Temperature, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LYNN LUCDERS
Address
14605 28th Ave. N. Minneapolis MN US 55447 55447

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K003145ORIGEN BLADDER HOLDEROrigen Biomedical, Inc.2001-04-20
K001520ALPHA OMEGA DUAL COOLER-HEATERAlpha Omega, Inc.2000-11-22
K945720JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICEJostra Bentley1995-03-29
K896971CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420Daily Medical Products, Inc.1990-02-05
K896972CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520Daily Medical Products, Inc.1990-02-05