CARDIOVENTION CORX SYSTEM, MODEL FG 0001— 510(k) K012325

Substantially Equivalent

Cardiovention, Inc.

FDA 510(k) clearance K012325 for CARDIOVENTION CORX SYSTEM, MODEL FG 0001, Substantially Equivalent on 2002-04-09. Applicant: Cardiovention, Inc..

Clearance details

Applicant: Cardiovention, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2001-07-23
Decision date: 2002-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.