DAIG VESSEL DILATOR

Dilator, Vessel, For Percutaneous Catheterization

DAIG CORP.

The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Vessel Dilator.

Pre-market Notification Details

Device IDK894330
510k NumberK894330
Device Name:DAIG VESSEL DILATOR
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant DAIG CORP. 14901 DEVEAU PLACE Minnetonka,  MN  55345 -2126
ContactJ Fleischhacker
CorrespondentJ Fleischhacker
DAIG CORP. 14901 DEVEAU PLACE Minnetonka,  MN  55345 -2126
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-09-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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05415067042576 K894330 000

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