ANGIOMAT 6000

Injector And Syringe, Angiographic

MALLINCKRODT GROUP, INC.

The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Angiomat 6000.

Pre-market Notification Details

Device IDK860204
510k NumberK860204
Device Name:ANGIOMAT 6000
ClassificationInjector And Syringe, Angiographic
Applicant MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati,  OH  45215 -6305
ContactJames S Adams
CorrespondentJames S Adams
MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati,  OH  45215 -6305
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-22
Decision Date1986-05-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10746190004219 K860204 000
20746190002021 K860204 000
10746190002017 K860204 000

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