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

Name: FDA 510(k) clearance K012520
Creator: U.S. Food and Drug Administration
Published: 2002-03-27

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.. 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: 2001-08-06
Decision date: 2002-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRF

view all

K252794 — Vision-MR Diagnostic Catheter2026-01-08
K250590 — MAGiC Sweep EP Mapping Catheter2025-07-23
K250310 — VIKING Fixed Curve Diagnostic Catheter2025-06-27
K240366 — EPXT Unidirectional Steerable Diagnostic Catheter +2 more2024-11-01
K233900 — Nordica PV Cryo Mapping Catheter2024-09-06

More clearances from Cardiac Assist Devices, Inc.

view all

K960849 — MAGNO ALARM1997-03-26
K955847 — GYRO TIP EP CATHETER1997-01-29

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.