MODIFICATION TO: CARDIMA ABLATION SYSTEM— 510(k) K060715

Substantially Equivalent

Cardima, Inc.

FDA 510(k) clearance K060715 for MODIFICATION TO: CARDIMA ABLATION SYSTEM, Substantially Equivalent on 2006-05-15. Applicant: Cardima, Inc..

Clearance details

Applicant: Cardima, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2006-03-17
Decision date: 2006-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.