GYRO TIP EP CATHETER— 510(k) K955847

Name: FDA 510(k) clearance K955847
Creator: U.S. Food and Drug Administration
Published: 1997-01-29

Substantially Equivalent

Cardiac Assist Devices, Inc.

FDA 510(k) clearance K955847 for GYRO TIP EP CATHETER, Substantially Equivalent on 1997-01-29. Applicant: Cardiac Assist Devices, Inc.. Device class: 2.

Clearance details

Applicant: Cardiac Assist Devices, Inc.
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1995-12-26
Decision date: 1997-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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K012520 — GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E2002-03-27
K960849 — MAGNO ALARM1997-03-26

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.