DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO

Introducer, Catheter

DAIG CORP.

The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Percutaneous Catheter Intro. & Removable Hemo.

Pre-market Notification Details

Device IDK894343
510k NumberK894343
Device Name:DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
ClassificationIntroducer, Catheter
Applicant DAIG CORP. 14901 DEVEAU PLACE Minnetonka,  MN  55345 -2126
ContactJ Fleischhacker
CorrespondentJ Fleischhacker
DAIG CORP. 14901 DEVEAU PLACE Minnetonka,  MN  55345 -2126
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-09-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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15414734216958 K894343 000
15414734216941 K894343 000
15414734021606 K894343 000

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