Medline Cardiovascular Procedure Kit

General Surgery Tray

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Cardiovascular Procedure Kit.

Pre-market Notification Details

Device IDK212258
510k NumberK212258
Device Name:Medline Cardiovascular Procedure Kit
ClassificationGeneral Surgery Tray
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactStephanie Augsburg
CorrespondentClaire Pigman
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-07-20
Decision Date2021-12-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00653160344356 K212258 000
00653160259476 K212258 000
00653160350067 K212258 000
00653160362138 K212258 000

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