K242588
- 510(k) number
- K242588
- Device name
- COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd. CN
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-01-07
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242588.pdf
Official FDA record: K242588
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.