ALT-006611K231207Green Status
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc. · Manufacturer
All identifiers (2)
Aletia (canonical)
ALT-006611FDA 510(k) · US (primary)
K231207Overview
Accountability Tier
Tier 2
Regulatory Registrations
🌐
US
FDA
ID: K231207
510k
Lifecycle Signals
Last Automated Sync
Jun 2026
Last Clinical Review
Not reviewed
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