KANEKA PHARMA AMERICA XPRESS-WAY RX

Catheter, Embolectomy

KANEKA PHARMA AMERICA LLC

The following data is part of a premarket notification filed by Kaneka Pharma America Llc with the FDA for Kaneka Pharma America Xpress-way Rx.

Pre-market Notification Details

Device IDK101839
510k NumberK101839
Device Name:KANEKA PHARMA AMERICA XPRESS-WAY RX
ClassificationCatheter, Embolectomy
Applicant KANEKA PHARMA AMERICA LLC 5 WENTWORTH DRIVE Hudson,  NH  03051
ContactRaymond Kelly
CorrespondentRaymond Kelly
KANEKA PHARMA AMERICA LLC 5 WENTWORTH DRIVE Hudson,  NH  03051
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-01
Decision Date2010-10-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04540778133983 K101839 000
04540778133976 K101839 000

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