ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493

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 Ultraset/3l Capd Disposable Disconnect Y-set Models 5c4366 & 5c4493.

Pre-market Notification Details

• Device ID: K961825
• 510k Number: K961825
• Device Name: ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
• Classification: Set, Administration, For Peritoneal Dialysis, Disposable
• Applicant: BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085
• Contact: David C Ross
• Correspondent: David C Ross; BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, 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: 1996-05-10
• Decision Date: 1996-08-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50085412090080	K961825	000
50085412030574	K961825	000