HERO GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

HEMOSHPERE, INC., A CRYOLIFE COMPANY

The following data is part of a premarket notification filed by Hemoshpere, Inc., A Cryolife Company with the FDA for Hero Graft.

Pre-market Notification Details

Device IDK124039
510k NumberK124039
Device Name:HERO GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant HEMOSHPERE, INC., A CRYOLIFE COMPANY 6545 CITY WEST PARKWAY Eden Prairie,  MN  55344
ContactLaurie Lynch
CorrespondentLaurie Lynch
HEMOSHPERE, INC., A CRYOLIFE COMPANY 6545 CITY WEST PARKWAY Eden Prairie,  MN  55344
Product CodeDSY  
Subsequent Product CodeLJS
Subsequent Product CodeMSD
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-28
Decision Date2013-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450310193 K124039 000
20884450282865 K124039 000
10884450282882 K124039 000
10884450282905 K124039 000
10884450288969 K124039 000
10884450288976 K124039 000
10884450309237 K124039 000
10884450309244 K124039 000
10884450310158 K124039 000
20884450310179 K124039 000
20884450282841 K124039 000

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