FDA Cleared
Existing Device (Modification)
Pathway: 510K
VIVO (9002)
Applicant:
Catheter Precision, Inc.
VIVO
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
DQK
Review Panel:
Cardiovascular
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-06-05
Decision Date:
2026-10-30
Total Review Duration:
147 calendar days (147 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Darci Diage
Role: SUBMITTER_CONTACT
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