VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING

Wire, Guide, Catheter

NEO METRICS, INC.

The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Vascupuncture Picc Guidewire With Hydro-silk Coating.

Pre-market Notification Details

Device IDK040786
510k NumberK040786
Device Name:VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
ClassificationWire, Guide, Catheter
Applicant NEO METRICS, INC. 14800 28TH AVENUE NORTH SUITE 150 Plymouth,  MN  55447
ContactGene Champeau
CorrespondentGene Champeau
NEO METRICS, INC. 14800 28TH AVENUE NORTH SUITE 150 Plymouth,  MN  55447
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-29
Decision Date2004-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40888277751973 K040786 000

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