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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 the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-01-07 under 510(k) 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. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K242588.

When did COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) receive FDA 510(k) clearance?

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

Who is the listed applicant for COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)?

The FDA 510(k) record lists OrbusNeich Medical (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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