Cleared Traditional

Cardioblate Gemini-s Surgical Ablation Device

K200514 · Medtronic · Cardiovascular
Jun 2020
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K200514 is an FDA 510(k) clearance for the Cardioblate Gemini-s Surgical Ablation Device, a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II — Special Controls, product code OCL), submitted by Medtronic (Minneapolis, US). The FDA issued a Cleared decision on June 3, 2020, 93 days after receiving the submission on March 2, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K200514 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date June 03, 2020
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code OCL — Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

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