FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL

Device, Neurovascular Embolization

BOSTON SCIENTIFIC, TARGET

The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Fibered Gdc-18 Vortx Shape Guglielmi Detachable Coil.

Pre-market Notification Details

Device IDK993418
510k NumberK993418
Device Name:FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
ClassificationDevice, Neurovascular Embolization
Applicant BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont,  CA  94538
ContactRoxane Baxter
CorrespondentRoxane Baxter
BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont,  CA  94538
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-01
Decision Date2000-01-21
Summary:summary

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