|
Device |
device, neurovascular embolization |
Product Code | HCG |
Regulation Number |
882.5950
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BALT USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOCOMPATIBLES U.K. LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSPHERE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BLOCKADE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CODMAN & SHURTLEFF, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CODMAN & SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CODMAN AND SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KANEKA MEDICAL AMERICA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KANEKA PHARMA AMERICA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROPORT NEUROTECH (SHANGHAI) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROVENTION, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K090001 V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
|
2. K090168 AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 4 ...
|
3. K090357 HYDROFRAME (HES)
|
4. K090891 MICROPLEX COIL SYSTEM-COSMOS
|
5. K091641 HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX ...
|
6. K093358 MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 18 ...
|
7. K093919 MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 1 ...
|
8. K100454 HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HF ...
|
9. K103758 MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM ...
|
10. K111451 MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 03 ...
|
11. K112181 HYDROCOIL(R) EMBOLIC SYSTEM (HES)
|
12. K112226 HYDROCOIL EMBOLIC SYSTEM (HES)
|
13. K113457 HYDROCOIL EMBOLIC SYSTEM (HES)
|
14. K120908 HYDROCOIL EMBOLIC SYSTEM (HES)
|
15. K131948 MICROPLEX COIL SYSTEM (MCS)
|
16. K132317 MICROPLEX COIL SYSTEM (MCS), VFC
|
17. K132952 MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYS ...
|
18. K153594 MicroPlex Coil System (MCS), Hydrocoil Embolic Sys ...
|
19. K161367 HydroCoil Embolic System (HES)
|
20. K161452 MicroPlex Coil System (MCS) - HyperSoft 3D
|
MICROVENTION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
20
|
1. K090001 V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
|
2. K090168 AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 4 ...
|
3. K090357 HYDROFRAME (HES)
|
4. K090891 MICROPLEX COIL SYSTEM-COSMOS
|
5. K091641 HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX ...
|
6. K093358 MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 18 ...
|
7. K093919 MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 1 ...
|
8. K100454 HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HF ...
|
9. K103758 MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM ...
|
10. K111451 MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 03 ...
|
11. K112181 HYDROCOIL(R) EMBOLIC SYSTEM (HES)
|
12. K112226 HYDROCOIL EMBOLIC SYSTEM (HES)
|
13. K113457 HYDROCOIL EMBOLIC SYSTEM (HES)
|
14. K120908 HYDROCOIL EMBOLIC SYSTEM (HES)
|
15. K131948 MICROPLEX COIL SYSTEM (MCS)
|
16. K132317 MICROPLEX COIL SYSTEM (MCS), VFC
|
17. K132952 MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYS ...
|
18. K153594 MicroPlex Coil System (MCS), Hydrocoil Embolic Sys ...
|
19. K161367 HydroCoil Embolic System (HES)
|
20. K161452 MicroPlex Coil System (MCS) - HyperSoft 3D
|
MICRUS ENDOVASCULAR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENUMBRA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
SPARTAN MICRO, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
WALLABY MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
BALT USA, LLC |
II |
Feb-08-2024 |
2 |
BALT USA, LLC |
II |
Oct-20-2022 |
3 |
BALT USA, LLC |
II |
Sep-06-2022 |
4 |
BALT USA, LLC |
II |
Feb-22-2022 |
5 |
Codman & Shurtleff Inc |
II |
Aug-15-2019 |
6 |
Micro Therapeutics Inc, dba ev3 Neurovascular |
III |
Jan-26-2012 |
7 |
Micro Therapeutics Inc, dba ev3 Neurovascular |
III |
Jan-24-2012 |
8 |
Micro Therapeutics, Inc. |
II |
Jun-13-2022 |
9 |
Microvention, Inc. |
II |
Feb-27-2020 |
10 |
Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 |
II |
Jan-03-2011 |
11 |
Penumbra Inc. |
I |
Apr-12-2011 |
12 |
Stryker Neurovascular |
II |
Jul-11-2016 |
13 |
Stryker Neurovascular |
II |
Apr-19-2016 |
14 |
Stryker Neurovascular |
II |
Dec-16-2014 |
15 |
Stryker Neurovascular |
II |
Dec-13-2013 |
|
|
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