INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,

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 S / Clearlink System / V-link Lad With Vitalshield Protective Coating Non-dehp Catheter Extension Set Kits,.

Pre-market Notification Details

• Device ID: K103551
• 510k Number: K103551
• Device Name: INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
• 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: No
• Date Received: 2010-12-02
• Decision Date: 2011-03-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412089411	K103551	000
50085412089398	K103551	000
50085412089022	K103551	000