Cleared Traditional

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

K242588 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Cardiovascular
Jan 2025
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K242588 is an FDA 510(k) clearance for the COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2025, 130 days after receiving the submission on August 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K242588 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date January 07, 2025
Days to Decision 130 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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