PERIPHERAL VASCULAR DILATOR

Dilator, Vessel, For Percutaneous Catheterization

ENDOVASCULAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Endovascular Instruments, Inc. with the FDA for Peripheral Vascular Dilator.

Pre-market Notification Details

Device IDK974617
510k NumberK974617
Device Name:PERIPHERAL VASCULAR DILATOR
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant ENDOVASCULAR INSTRUMENTS, INC. 1800 EAST 900 SOUTH Saltlake City,  UT  84108
ContactJack Speer
CorrespondentJack Speer
ENDOVASCULAR INSTRUMENTS, INC. 1800 EAST 900 SOUTH Saltlake City,  UT  84108
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-11
Decision Date1998-12-01
Summary:summary

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