ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U

Marker, Radiographic, Implantable

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Ultraclip Ii Us Wing And Coil, Models: 862017u, 864017u.

Pre-market Notification Details

Device IDK090547
510k NumberK090547
Device Name:ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
ClassificationMarker, Radiographic, Implantable
Applicant C.R. BARD, INC. 1625 WEST 3RD ST. Tempe,  AZ  85281 -2438
ContactCindy Moss
CorrespondentCindy Moss
C.R. BARD, INC. 1625 WEST 3RD ST. Tempe,  AZ  85281 -2438
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-02
Decision Date2009-03-18
Summary:summary

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