3 PORT ADAPTER

Set, Administration, Intravascular

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 3 Port Adapter.

Pre-market Notification Details

Device IDK913627
510k NumberK913627
Device Name:3 PORT ADAPTER
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
ContactMarcia Marconi
CorrespondentMarcia Marconi
BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-15
Decision Date1991-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412048500 K913627 000

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