QUADRASPHERE 30 TO 60

Device, Neurovascular Embolization

BIOSPHERE MEDICAL, INC.

The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Quadrasphere 30 To 60.

Pre-market Notification Details

Device IDK113822
510k NumberK113822
Device Name:QUADRASPHERE 30 TO 60
ClassificationDevice, Neurovascular Embolization
Applicant BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland,  MA  02370
ContactLinda J Varroso
CorrespondentLinda J Varroso
BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland,  MA  02370
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-27
Decision Date2012-03-08
Summary:summary

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