Panels › General Hospital › Product code LJS · Class 2

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Regulation 880.5970

4510(k)s in 12 months (303 all time)

9recalls in 12 months (332 all time)

305recalls that name a 510(k)

Top companies in LJS

Company	510(k)s	Recalls
Arrow International, Inc.	5	84
Angiodynamics Inc. (Navilyst Medical Inc.)	0	54
Bard Access Systems, Inc.	6	39
Angiodynamics Worldwide Headquarters	0	39
C.R. Bard, Inc.	34	0
Navilyst Medical, Inc.	16	12
Navilyst Medical, Inc., an AngioDyamics Company	0	23
Boston Scientific	2	18
Cook Incorporated	9	10
Vygon Corp.	12	4

Decided	510(k)	Device and applicant	Code
Mar 1, 1983	K830256	NON-STERILE BROVIAC PARENTERAL ALIMI- Evermed, Inc.	LJS
Feb 28, 1983	K830233	NON-STERILE,SINGLE/SOUBLE LUMEN-CATH Evermed, Inc.	LJS
Jan 5, 1983	K823553	CORCATH H & B VASCULAR ACCESS CATHETER Cormed, Inc., Sub. C.R.Bard, Inc.	LJS

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