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701
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510
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485
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483
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435
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403
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391
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345
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343
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Manufacturers
US
Zoll Circulation
Medical Device Manufacturer
·
US , Sunnyvale , CA
Zoll Circulation - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2006
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zoll Circulation
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139
·
NCX
Neurology
·
154d
Cleared
Oct 12, 2010
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO...
K101987
·
NCX
Neurology
·
90d
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5
Cardiovascular
3
Neurology
2