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520
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489
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403
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400
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392
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Manufacturers
US
Ev3 Corporation
Medical Device Manufacturer
·
US , Plymouth , MN
Ev3 Corporation - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2003
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ev3 Corporation
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 08, 2004
X-SIZER CATHETER SYSTEM
K021096
·
MCW
Cardiovascular
·
888d
Cleared
Jun 24, 2003
NITREX NITINOL GUIDEWIRE
K031864
·
DQX
Cardiovascular
·
8d
Cleared
Jan 24, 2003
NITREX NITINOL GUIDEWIRE
K024021
·
DQX
Cardiovascular
·
50d
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5
Cardiovascular
3
Gastroenterology & Urology
2