510(k) K241507
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2024
- Date Received
- May 28, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Intravascular, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.3375
- Review Panel
- CV
- Submission Type