CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015

Occluder, Catheter Tip

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Coronary Ostium Occluder, Catalog Code 32015.

Pre-market Notification Details

Device IDK880860
510k NumberK880860
Device Name:CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
ClassificationOccluder, Catheter Tip
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactVan Hof
CorrespondentVan Hof
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeDQT  
CFR Regulation Number870.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-01
Decision Date1988-05-26

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