HeRO Graft

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Hero Graft.

Pre-market Notification Details

Device IDK172637
510k NumberK172637
Device Name:HeRO Graft
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactSusan Christensen
CorrespondentSusan Christensen
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeDSY  
Subsequent Product CodeLJS
Subsequent Product CodeMSD
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-01
Decision Date2017-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884450386528 K172637 000
10884450386511 K172637 000
10884450329556 K172637 000
10884450320560 K172637 000
10884450320546 K172637 000
10884450385682 K172637 000
20884450385672 K172637 000

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