510(k) K213314
K213314 is an FDA 510(k) premarket notification submitted by Cerus Endovascular, Inc. for the device "CerusEndo Microcatheter (027)". The FDA issued a decision of Substantially Equivalent on Mar 15, 2022. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250. Cerus Endovascular, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 2022
- Date Received
- Oct 4, 2021
- Clearance Type
- Traditional
- 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