510(k) K253323
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2025
- Date Received
- September 30, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peripheral Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.