Acute Dual Lumen Hemodialysis Catheter

Catheter, Hemodialysis, Non-implanted

Health Line International Corporation

The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Acute Dual Lumen Hemodialysis Catheter.

Pre-market Notification Details

Device IDK200426
510k NumberK200426
Device Name:Acute Dual Lumen Hemodialysis Catheter
ClassificationCatheter, Hemodialysis, Non-implanted
Applicant Health Line International Corporation 5675 West 300 South Salt Lake City,  UT  84104
ContactAaron G. Faulkner
CorrespondentAaron G. Faulkner
Health Line International Corporation 5675 West 300 South Salt Lake City,  UT  84104
Product CodeMPB  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-21
Decision Date2020-12-24

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.