VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM

Device, Anastomotic, Microvascular

VIOPTIX, INC.

The following data is part of a premarket notification filed by Vioptix, Inc. with the FDA for Vesselink Microvascular Anastomotic Coupler System.

Pre-market Notification Details

Device IDK090679
510k NumberK090679
Device Name:VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
ClassificationDevice, Anastomotic, Microvascular
Applicant VIOPTIX, INC. 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactGrace Holland
CorrespondentGrace Holland
VIOPTIX, INC. 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeMVR  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-16
Decision Date2009-04-17
Summary:summary

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