|
Device |
catheter, percutaneous |
Regulation Description |
Percutaneous catheter. |
Product Code | DQY |
Regulation Number |
870.1250
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT (ST. JUDE MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ABBOTT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
ALEMBIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASHITAKA FACTORY OF TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCARDIA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTRONIK, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTRONIK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
C.R. BARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOVASCULAR SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CENTERPOINT SYSTEMS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CORDIS US CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CRUZAR MEDSYSTEMS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EOSOLUTIONS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HAOLANG MEDICAL USA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEXACATH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMDS OPERATIONS B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
INARI MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNEUROCO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARVAO MEDICAL DEVICES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROVENTION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MIVI NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NITILOOP LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OKAMI MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PENUMBRA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QXMEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REFLOW MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
REFLOW MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROUTE 92 MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEIGLA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIMPSON INTERVENTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K240885 Shadow Catheter
|
SPARTAN MICRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURMODICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURMODICS. INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSIT SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSIT SCIENTIFIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRAVERSE VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRISALUS LIFE SCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VANTIS VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
WALLABY MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALLABY MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|