MAGIC Infusion Catheter

Catheter, Continuous Flush

Balt USA, LLC

The following data is part of a premarket notification filed by Balt Usa, Llc with the FDA for Magic Infusion Catheter.

Pre-market Notification Details

Device IDK202366
510k NumberK202366
Device Name:MAGIC Infusion Catheter
ClassificationCatheter, Continuous Flush
Applicant Balt USA, LLC 29 Parker Irvine,  CA  92618
ContactCorina Pierson
CorrespondentCorina Pierson
Balt USA, LLC 29 Parker Irvine,  CA  92618
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2021-01-29

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