Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200

Catheter, Continuous Flush

Thrombolex, Inc.

The following data is part of a premarket notification filed by Thrombolex, Inc. with the FDA for Bashir Endovascular Catheter Model 7201, Bashir N-x Endovascular Catheter, Mode 7200.

Pre-market Notification Details

Device IDK183290
510k NumberK183290
Device Name:Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
ClassificationCatheter, Continuous Flush
Applicant Thrombolex, Inc. 51 Britain Dr. New Britain,  PA  18901
ContactAmy Katsikis
CorrespondentDiane Horwitz
Eminence Clinical Research Inc. 2995 Steven Martin Dr. Fairfax,  VA  22031
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-26
Decision Date2019-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850005115014 K183290 000
00850005115007 K183290 000

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