Medical Device Manufacturer · CA , Burnaby

Kardium, Inc.

2 submissions · 2 cleared · Since 2025
2
Total
2
Cleared
0
Denied

Kardium, Inc. — FDA 510(k) Submissions

Kardium, Inc. has submitted 2 FDA 510(k) premarket notifications since 2025, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Steerable, Computer, Diagnostic, Programmable . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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All2 Cardiovascular 2