|
Device |
wire, guide, catheter |
Regulation Description |
Catheter guide wire. |
Product Code | DQX |
Regulation Number |
870.1330
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ABBOTT VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASAHI INTECC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMERICS NLE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDIO FLOW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTURION MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
LAKE REGION MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OPSENS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SCIENTIA VASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEVEN SONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPARTAN MICRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASCULAR SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VESATEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOLCANO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WILLIAM COOK EUROPE APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|