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Manufacturers
US
Hemosphere, Inc.
Medical Device Manufacturer
·
US , Eden Prarie , MN
Hemosphere, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2009
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hemosphere, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 22, 2012
HERO GRAFT
K121532
·
DSY
Cardiovascular
·
29d
Cleared
Feb 02, 2012
HERO GRAFT
K120006
·
DSY
Cardiovascular
·
30d
Cleared
Jul 31, 2009
HERO VASCULAR ACCESS DEVICE
K091491
·
DSY
Cardiovascular
·
72d
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Cardiovascular
3