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Manufacturers
US
Cardio Tek, BV
Medical Device Manufacturer
·
US , Ballwin , MO
Cardio Tek, BV - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2014
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardio Tek, BV
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 05, 2016
EP-TRACER System
K161245
·
DQK
Cardiovascular
·
94d
Cleared
Mar 31, 2014
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
K134044
·
DQK
Cardiovascular
·
90d
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2
Cardiovascular
2