INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

Set, Administration, Intravascular

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink System Lever Lock Cannula With Check Valve, Secondary Medication Sets, Solution Sets, Continu-flo Solution Set.

Pre-market Notification Details

Device IDK123868
510k NumberK123868
Device Name:INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake,  IL  60073
ContactGary Chumbimune
CorrespondentGary Chumbimune
BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-17
Decision Date2013-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412068669 K123868 000
50085412000546 K123868 000
50085412002113 K123868 000
50085412002120 K123868 000
50085412002199 K123868 000
50085412002243 K123868 000
50085412002250 K123868 000
50085412002267 K123868 000
50085412002571 K123868 000
50085412002588 K123868 000
50085412004353 K123868 000
50085412045752 K123868 000
50085412068195 K123868 000
50085412000522 K123868 000

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