VIVO (9002)— 510(k) K261886

Name: FDA 510(k) clearance K261886
Creator: U.S. Food and Drug Administration
Published: 2026-10-30

Substantially Equivalent

Catheter Precision, Inc.

FDA 510(k) clearance K261886 for VIVO (9002), Substantially Equivalent on 2026-10-30. Applicant: Catheter Precision, Inc.. Device class: 2.

Clearance details

Applicant: Catheter Precision, Inc.
Product code: Product code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2026-06-05
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Mill, SC, US

Download summary PDF View on FDA.gov ↗

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K263016 — Intra-Operative Positioning System (IOPS) and IOPS Visionary System2026-10-01
K254255 — S-Patch CardioAI2026-09-25
K261729 — EnSite X EP System2026-09-17

More clearances from Catheter Precision, Inc.

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K200313 — VIVO2020-09-14
K183195 — VIVO2019-06-14

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.