ClearanceBrief
Panels › Cardiovascular › Product code DXE · Class 2

Catheter, Embolectomy

Regulation 870.5150

0510(k)s in 12 months (74 all time)
2recalls in 12 months (58 all time)
56recalls that name a 510(k)
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Top companies in DXE

Company510(k)sRecalls
LeMaitre Vascular, Inc.123
Arrow International Inc010
Edwards Lifesciences64
Applied Medical Resources44
Boston Scientific Corporation05
Shiley, Inc.50
Cathlab Corp.40
Ideas For Medicine, Inc.40
Lucas Medical, Inc.40
Vascutech, Inc.40
Decided510(k)Device and applicantCode
Dec 7, 1989K883852CATHETER, CARDIOVASCULAR, BALLOON TYPE
Wb Intl., Inc.
DXE
Oct 12, 1989K894681REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
Shiley, Inc.
DXE
Sep 18, 1989K891021TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
Ideal Medical, Inc.
DXE
Aug 1, 1989K893680SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
Cathlab Corp.
DXE
Jul 20, 1989K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
Baxter Healthcare Corp
DXE
Jun 15, 1988K881455EMBOLECTOMY CATHETER(MODIFIED)
Cathlab Corp.
DXE
Aug 12, 1987K872485CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
Ideas For Medicine, Inc.
DXE
Jan 6, 1987K864330SHEAR FORCE GAUGE
American Edwards Laboratories
DXE
Jan 6, 1987K864062PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
Ideas For Medicine, Inc.
DXE
Jan 2, 1987K864007EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
Uresil Corp.
DXE
Jan 15, 1986K853625NOVA ARTERIAL EMBOLECTOMY CATHETER
Nova Medical Specialties
DXE
Jun 19, 1985K850015POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
Polymed Laboratories
DXE
Aug 3, 1984K840198ARTERIAL EMBOLECTOMY CATHETER
Shiley, Inc.
DXE
Sep 29, 1983K832044SHILEY MULTIPRO CATHETER
Shiley, Inc.
DXE
Aug 31, 1983K832023EMBOLECTOMY CATHETER
Bionomy, Inc.
DXE
Mar 25, 1982K820646ATRAC TM MULTIPURPOSE BALLOON CATHETER
Atrium Medical Corp.
DXE
Oct 2, 1981K812640URE SIL EMBOLECTOMY/THROMBECTOMY CATH
Uresil Corp.
DXE
Aug 4, 1980K801650DESERET EMBOLECTOMY/THROMBECTOMY CATH.
Deseret Medical, Inc.
DXE
Jun 11, 1979K790838ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
Shiley, Inc.
DXE
May 26, 1978K780762EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
Shiley, Inc.
DXE
Apr 13, 1978K780244CATHETERS, ARTERIAL EMBOLECTOMY
Extracorporeal Medical Specialities, Inc.
DXE
Apr 27, 1977K770714CATHETER, ARTERIAL EMBOLECTOMY
Mallinckrodt Critical Care
DXE
Apr 5, 1977K770569CATHETER, EMBOLECTOMY, UMI
Universal Medical Instrument Corp.
DXE
Dec 13, 1976K761031ELECATH ARTERIAL EMBOLECTOMY CATHETER
Electro-Catheter Corp.
DXE

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