PBN GUIDEWIRES

Wire, Guide, Catheter

MEDICAL DEVICE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Pbn Guidewires.

Pre-market Notification Details

Device IDK031442
510k NumberK031442
Device Name:PBN GUIDEWIRES
ClassificationWire, Guide, Catheter
Applicant MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville,  FL  32608
ContactKarl Swartz
CorrespondentKarl Swartz
MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville,  FL  32608
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-06
Decision Date2003-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886333000757 K031442 000
20886333000740 K031442 000
20886333000733 K031442 000

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