GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E— 510(k) K012520

Substantially Equivalent

Cardiac Assist Devices, Inc.

FDA 510(k) clearance K012520 for GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E, Substantially Equivalent on 2002-03-27. Applicant: Cardiac Assist Devices, Inc..

Clearance details

Applicant: Cardiac Assist Devices, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2001-08-06
Decision date: 2002-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.