COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (K242588)
Description
COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) by OrbusNeich Medical (Shenzhen) Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242588
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (K242588) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., ... | 2024 |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold ... | Vascular Solutions, LLC | 2019 |
| K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | 2018 |
Trace the full predicate network for K242588
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.