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/ Cardiosense, Inc.
Cardiosense, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
DEN250057
PCWP Analysis Software
May 22, 2026
K243566
CardioTag
July 22, 2025