V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE

Set, Administration, Intravascular

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for V-link Antimicrobial Luer Activated Device And Extension Sets With V-link Antimicrobial Luer Activated Device.

Pre-market Notification Details

• Device ID: K081289
• 510k Number: K081289
• Device Name: V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
• Classification: Set, Administration, Intravascular
• Applicant: BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085
• Contact: Nanette Hedden
• Correspondent: Nanette Hedden; BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2008-05-07
• Decision Date: 2008-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412088346	K081289	000
50085412088322	K081289	000
50085412088308	K081289	000