Cleared Traditional

Cosine-10TM Diagnostic Catheter

K233397 · Medtronic, Inc. · Cardiovascular
Dec 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K233397 is an FDA 510(k) clearance for the Cosine-10TM Diagnostic Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 2, 2023, 60 days after receiving the submission on October 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K233397 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2023
Decision Date December 02, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

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