SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE

Set, Administration, Intravascular

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Solution Administration Sets With Capless Luer Activated Valve.

Pre-market Notification Details

• Device ID: K003225
• 510k Number: K003225
• Device Name: SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
• Classification: Set, Administration, Intravascular
• Applicant: BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073
• Contact: Mary Ellen Snyder
• Correspondent: Mary Ellen Snyder; BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-16
• Decision Date: 2000-10-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10193489777772	K003225	000
10193489462302	K003225	000
40193489365703	K003225	000
40193489380805	K003225	000