510(k) K243403
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2025
- Date Received
- October 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type