ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE— 510(k) K102588

Clearance details

Applicant

Medtronic Ablation Frontiers, LLC

Product code

Code DRF

Device class

Class 2

Regulation

21 CFR 870.1220

Advisory panel

Cardiovascular

Date received

2010-09-09

Decision date

2011-03-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

• 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

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 →

• Z-0200-2016 — Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.Class II·Terminated·Medtronic Inc.·20150929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102588.