|
|
| Device |
wire, guide, catheter |
| Product Code | DQX |
| Regulation Number |
870.1330
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ABBOTT VASCULAR |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| 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
|
16
|
| ASAHI INTECC CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ASHITAKA FACTORY OF TERUMO COPORATION |
| |
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 CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| BOSTON SCIENTIFIC INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BRIVANT LIMITED (LAKE REGION MEDICAL) |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CARDIO FLOW, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CENTURION MEDICAL PRODUCTS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CONCERT MEDICAL, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COOK INCORPORATED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COOK INCORPORATED |
| |
SUBSTANTIALLY EQUIVALENT
|
10
|
| EMBRACE MEDICAL LTD. |
| |
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
|
| HERAEUS MEDICAL COMPONENTS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| LAKE REGION MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| MEDTRONIC CORE VALVE, LLC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDTRONIC VASCULAR |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MERIT MEDICAL SYSTEM, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MERIT MEDICAL SYSTEMS INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MERIT MEDICAL SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| NANO4IMAGING GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| OPSENS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OPSENS INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| 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
|
| SPARTAN MICRO, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. |
| |
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
|
| TERUMO CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| TEXAS MEDICAL TECHNOLOGIES, INC. |
| |
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
|
4
|
| VESATEK, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| VOLCANO CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| WILLIAM COOK EUROPE APS |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|
