Cleared Traditional

FlexCath Contour? Steerable Sheath

K232321 · Medtronic, Inc. · Cardiovascular
Oct 2023
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K232321 is an FDA 510(k) clearance for the FlexCath Contour? Steerable Sheath, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on October 31, 2023, 89 days after receiving the submission on August 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K232321 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2023
Decision Date October 31, 2023
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

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