DeviceClearance

CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2— 510(k) K132782

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K132782 for CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2, Substantially Equivalent on 2014-01-24. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Diamond Bar, CA, US
Download summary PDFView on FDA.gov ↗

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K132782

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132782.

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