SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER

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 Set With 1.2 Micron Air Eliminating Filter.

Pre-market Notification Details

• Device ID: K952074
• 510k Number: K952074
• Device Name: SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
• Classification: Set, Administration, Intravascular
• Applicant: BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073
• Contact: Mary Ellen Snyder
• Correspondent: Mary Ellen Snyder; BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-05-02
• Decision Date: 1995-07-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412074769	K952074	000
50085412046438	K952074	000
50085412000508	K952074	000