THE AMPLANTZ GOOSE NECK MICROSNARE

Catheter, Percutaneous

MICROVENA CORP.

The following data is part of a premarket notification filed by Microvena Corp. with the FDA for The Amplantz Goose Neck Microsnare.

Pre-market Notification Details

Device IDK970668
510k NumberK970668
Device Name:THE AMPLANTZ GOOSE NECK MICROSNARE
ClassificationCatheter, Percutaneous
Applicant MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake,  MN  55110 -5426
ContactKaren Bannick
CorrespondentKaren Bannick
MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake,  MN  55110 -5426
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-24
Decision Date1998-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684005057 K970668 000
00763000225384 K970668 000
00763000225391 K970668 000
00763000225407 K970668 000
00763000225414 K970668 000
00763000225421 K970668 000
00821684005019 K970668 000
00821684005026 K970668 000
00821684005040 K970668 000
00763000225377 K970668 000

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