|
Device |
wire, guide, catheter |
Product Code | DQX |
Regulation Number |
870.1330
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ABBOTT VASCULAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ABBOTT VASCULAR-CARDIAC THERAPIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ACME-MONACO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARGON MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
28
|
ASAHI INTECC CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASHITAKA FACTORY OF TERUMO COPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASHITAKA FACTORY OF TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMERICS NLE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
BOSTON SCIENTIFIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIDGEPOINT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BRIVANT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIVANT LIMITED (LAKE REGION MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIVANT, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CARDIO FLOW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOSOLUTIONS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTURION MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CODMAN & SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COEUR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONCERT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
COOK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DISTAL ACCESS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELCAM MEDICAL A.C.A.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMBRACE MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FILMEC CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FILMECC CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FILMECC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FILMECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FLAT MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FMD CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GUIDEPATH MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS MEDICAL COMPONENTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LAKE REGION MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
LAKE REGION MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAKE REGION MFG., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDCOMP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIVALVE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC CORE VALVE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC COREVALVE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MENNEN MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
MICRO THERAPEUTICS, INC D/B/A: EV3 INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROVENTION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICRUS ENDOVASCULAR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANO4IMAGING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NAVIS MEDICAL,INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEEDLETECH PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEO METRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOMETRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPSENS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPSENS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OPSENS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSCOR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHENOX LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA CARDIO ACCESS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SEVEN SONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHEPHERD SCIENTIFIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPARTAN MICRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STEREOTAXIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUREFIRE MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TATARA VASCULAR, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHDEVICE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TERUMO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEXAS MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VADISWIRE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASCULAR SOLUTIONS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
VESATEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VOLCANO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
WILLIAM COOK EUROPE APS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|