510(k) K250962
K250962 is an FDA 510(k) premarket notification submitted by Alembic, LLC for the device "APRO 55 Intermediate Catheter". The FDA issued a decision of Substantially Equivalent on April 29, 2025. The device falls under product code DQY (Catheter, Percutaneous), 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
- April 29, 2025
- Date Received
- March 31, 2025
- Clearance Type
- Special
- 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