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510(k) K130039 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

Applicant	Gambro Renal Products, Inc., Lakewood CO, US
Decision	Substantially Equivalent, May 2, 2013
Received	Jan 7, 2013
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K130039

Date	Firm and product	Code	Linked 510(k)
Dec 22, 2022	Baxter Healthcare Corporation Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis. Open, Classified	KDI	None listed
Dec 22, 2022	Baxter Healthcare Corporation Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. Open, Classified	KDI	None listed
Dec 22, 2022	Baxter Healthcare Corporation Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. Open, Classified	KDI	None listed
Dec 22, 2022	Baxter Healthcare Corporation Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. Open, Classified	KDI	None listed
Nov 15, 2019	Baxter Healthcare Corporation Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L Terminated	KDI	None listed
May 31, 2019	Baxter Healthcare Corporation REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. Terminated	KDI	None listed
May 31, 2019	Baxter Healthcare Corporation REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. Terminated	KDI	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.