510(k) K243297
K243297 is an FDA 510(k) premarket notification submitted by Alembic, LLC for the device "APRO 70 Swift Catheter". The FDA issued a decision of Substantially Equivalent on January 14, 2025. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Alembic, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2025
- Date Received
- October 18, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
To provide vascular access to the neurovasculature for interventional or diagnostic procedures