Panels › Cardiovascular › Product code LIT · Class 2

Catheter, Angioplasty, Peripheral, Transluminal

Regulation 870.1250

5510(k)s in 12 months (405 all time)

2recalls in 12 months (32 all time)

28recalls that name a 510(k)

Top companies in LIT

Company	510(k)s	Recalls
Boston Scientific	52	8
Cordis Corp.	30	6
Meadox Medicals, Div. Boston Scientific Corp.	14	0
Vas-Cath, Inc.	14	0
C.R. Bard, Inc.	13	0
Cook Incorporated	13	0
Scimed Life Systems, Inc.	13	0
Advanced Cardiovascular Systems, Inc.	10	0
Biotronik AG	10	0
Ev3, Inc.	7	3

Decided	510(k)	Device and applicant	Code
Mar 24, 1983	K830608	USCI GRUNTZIG DILACA BALLOON DILATION C.R. Bard, Inc.	LIT
Aug 31, 1982	K822245	INDEFLATOR Advanced Cardiovascular Systems, Inc.	LIT
Dec 29, 1981	K813331	P51 ANGIOPLASTY PRESSURE TRANSDUCER Konigsberg Instruments, Inc.	LIT
Aug 31, 1981	K812168	CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. Cordis Corp.	LIT
Jan 13, 1981	K803057	FOGARTY BALLON ANGIOPLASTY CATHETERS American Edwards Laboratories	LIT

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