MEDLINE HIGH PRESSURE INJECTION TUBING

Catheter, Intravascular, Diagnostic

MEDLINE, INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline High Pressure Injection Tubing.

Pre-market Notification Details

Device IDK120008
510k NumberK120008
Device Name:MEDLINE HIGH PRESSURE INJECTION TUBING
ClassificationCatheter, Intravascular, Diagnostic
Applicant MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-08-17

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