# FDA 483 - Baxter Healthcare Corporation, Renal Division - Unknown Date

Source: https://www.keypedia.com/records/483/baxter-healthcare-corporation-renal-division/f35e30e2-6136-4c00-ab36-8309e58de893

> FDA 483 for Baxter Healthcare Corporation, Renal Division on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Corporation, Renal Division
- Product Type: device
- Office Name: Human Foods Program
- Summary: This document is a 510(k) summary for Baxter Healthcare Corporation, Renal Division, located in McGaw Park, IL. It describes the Ultra Set CAPD Disposable Disconnect Y-Set, a peritoneal dialysis system accessory. The submission aims to demonstrate substantial equivalence to previously cleared devices for drainage and infusion of PD solution.

Company: https://www.keypedia.com/companies/baxter-healthcare-corporation-renal-division/4d493b34-635b-480d-9436-a0762794378d

Office: https://www.keypedia.com/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324