Cleared Traditional

MitraClip? G5 Steerable Guide Catheter (SGC0801); TriClip? G5 Steerable Guide Catheter (TSGC0801)

K243224 · Abbott Medical · Cardiovascular
Dec 2024
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K243224 is an FDA 510(k) clearance for the MitraClip? G5 Steerable Guide Catheter (SGC0801); TriClip? G5 Steerable Guide Catheter (TSGC0801), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on December 31, 2024, 85 days after receiving the submission on October 7, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K243224 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2024
Decision Date December 31, 2024
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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