510(k) K242588
K242588 is an FDA 510(k) premarket notification submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. for the device "COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)". The FDA issued a decision of Substantially Equivalent on January 7, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. OrbusNeich Medical (Shenzhen) Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2025
- Date Received
- August 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type