MODIFIED HYDROPHILIC COATED GUIDEWIRE

Wire, Guide, Catheter

LAKE REGION MFG., INC.

The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Modified Hydrophilic Coated Guidewire.

Pre-market Notification Details

Device IDK000011
510k NumberK000011
Device Name:MODIFIED HYDROPHILIC COATED GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJim Klosterman
CorrespondentJim Klosterman
LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-03
Decision Date2000-03-01

NIH GUDID Devices

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