BAXTER APD 12' EXTENSION LINE

Set, Administration, For Peritoneal Dialysis, Disposable

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Apd 12' Extension Line.

Pre-market Notification Details

• Device ID: K925403
• 510k Number: K925403
• Device Name: BAXTER APD 12' EXTENSION LINE
• Classification: Set, Administration, For Peritoneal Dialysis, Disposable
• Applicant: BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. Mcgaw Pk, IL 60085
• Contact: Amy Stueber
• Correspondent: Amy Stueber; BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. Mcgaw Pk, IL 60085
• Product Code: KDJ
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-10-23
• Decision Date: 1994-02-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412087387	K925403	000