Medline Reinforced Epidural Catheter

Catheter, Conduction, Anesthetic

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Reinforced Epidural Catheter.

Pre-market Notification Details

Device IDK181782
510k NumberK181782
Device Name:Medline Reinforced Epidural Catheter
ClassificationCatheter, Conduction, Anesthetic
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactClaire Pigman
CorrespondentClaire Pigman
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeBSO  
CFR Regulation Number868.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-03
Decision Date2019-03-04

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