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FDA 510(k)

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

K-Number: K242588 · 2025-01-07

ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
Decision Date2025-01-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is a medical device manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-01-07 under approval number K242588. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is a medical device that received FDA 510(k) clearance on 2025-01-07. It is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K242588.

When was COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) approved by the FDA?

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) received FDA 510(k) clearance on 2025-01-07, under approval number K242588.

What company makes COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd..

What is the FDA product code for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

The FDA product code for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) is DQY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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