Panels › Gastroenterology, Urology › Product code KDJ · Class 2

Set, Administration, For Peritoneal Dialysis, Disposable

Regulation 876.5630

0510(k)s in 12 months (113 all time)

0recalls in 12 months (61 all time)

38recalls that name a 510(k)

Top companies in KDJ

Company	510(k)s	Recalls
Baxter Healthcare	16	49
National Medical Care, Medical Products Div., Inc.	30	0
Travenol Laboratories, S.A.	12	0
Fresenius Medical Care Holdings, Inc.	0	10
Abbott Laboratories	7	0
American Medical Products, Inc.	7	0
Delmed, Inc.	6	0
Fresenius Medical Care North America	3	1
Fresenius Medical Care Renal Therapies Group, LLC	4	0
Dravon Medical, Inc.	3	0

Decided	510(k)	Device and applicant	Code
Aug 12, 1980	K801193	CLIRANS TE15 HOLLOW FIBER DIALYZER Terumo America, Inc.	KDJ
Aug 12, 1980	K800993	INPERSOL CAPD ADMIN. SET & CATHETER ADAP Abbott Laboratories	KDJ
Feb 6, 1980	K792651	CAPD TRANSFER SET JC9044 Travenol Laboratories, S.A.	KDJ
Feb 6, 1980	K791512	CONTINUOUS AMBULATORY DIALYSIS (CAPD) Norton Performance Plastics Corp.	KDJ
Nov 16, 1979	K791722	DISPOSABLE PERITONEAL DIALYSIS EXTENSION American Medical Products, Inc.	KDJ
Nov 13, 1979	K791899	CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 Travenol Laboratories, S.A.	KDJ
Aug 28, 1979	K791426	PERITONEAL PAC Intermed, Inc.	KDJ
Feb 15, 1979	K781755	DAP-PAK Dravon Medical, Inc.	KDJ
Jul 6, 1978	K780957	SET, ADMINISTRATION, MANUAL, DIALYSIS American Medical Products, Inc.	KDJ
Jan 24, 1978	K780082	PERITONEAL DIALYSIS ADMIN. SET Physio-Control Corp.	KDJ
Jan 24, 1978	K772236	FILTER, PERITONEAL DIALY. ADMIN. SET Millipore Corp.	KDJ
Jan 3, 1978	K771482	RINSE BLOCK CONNECTOR Quinton, Inc.	KDJ
Dec 20, 1977	K772136	PERITONEAL CYCLER & MANIFOLD SET Physio-Control Corp.	KDJ

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