CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8— 510(k) K042999

Name: FDA 510(k) clearance K042999
Creator: U.S. Food and Drug Administration
Published: 2005-03-21

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K042999 for CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8, Substantially Equivalent on 2005-03-21. Applicant: Biosense Webster, Inc.. Device class: 2.

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2004-11-01
Decision date: 2005-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

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K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

More clearances from Biosense Webster, Inc.

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K252972 — CARTO 3 EP Navigation System V8.42026-02-20
K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus2026-01-18
K252302 — CARTO 3 EP Navigation System V8.12025-08-22
K241540 — NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter2024-06-28
K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter2024-06-12

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.