PaxWire Occlusion Balloon System

Catheter, Intravascular Occluding, Temporary

ACCESSCLOSURE, INC.

The following data is part of a premarket notification filed by Accessclosure, Inc. with the FDA for Paxwire Occlusion Balloon System.

Pre-market Notification Details

Device IDK143613
510k NumberK143613
Device Name:PaxWire Occlusion Balloon System
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant ACCESSCLOSURE, INC. 5452 Besty Ross Drive Santa Clara,  CA  95054
ContactKelly Jabbal
CorrespondentKelly Jabbal
ACCESSCLOSURE, INC. 5452 Besty Ross Drive Santa Clara,  CA  95054
Product CodeMJN  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-19
Decision Date2015-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M465ACX10106 K143613 000

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