510(k) K203840
K203840 is an FDA 510(k) premarket notification submitted by Marblehead Medical, LLC for the device "BOSS 8F Balloon Guide Catheter". The FDA issued a decision of Substantially Equivalent on Jan 28, 2021. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Marblehead Medical, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 28, 2021
- Date Received
- Dec 31, 2020
- 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
- 510(k)
To provide vascular access to the neurovasculature for interventional or diagnostic procedures