GDC ULTRASOFT 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 Gdc Ultrasoft Coil.

Pre-market Notification Details

Device IDK002181
510k NumberK002181
Device Name:GDC ULTRASOFT COIL
ClassificationDevice, Neurovascular Embolization
Applicant BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont,  CA  94538
ContactJames Leathley
CorrespondentJames Leathley
BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont,  CA  94538
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-19
Decision Date2000-08-11

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