ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1— 510(k) K061593

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K061593 for ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1, Substantially Equivalent on 2006-07-12. Applicant: AtriCure, Inc..

Clearance details

Applicant: AtriCure, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 2006-06-08
Decision date: 2006-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, 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.