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435
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362
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284
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272
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Manufacturers
Arravasc, Ltd.
Medical Device Manufacturer
·
IE , Galway
Arravasc, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arravasc, Ltd.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 31, 2017
Pirouette High Pressure (HP)
K172033
·
LIT
Cardiovascular
·
57d
Cleared
Nov 22, 2016
Pirouette 014
K162316
·
LIT
Cardiovascular
·
96d
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Cardiovascular
2