510(k) K230402
K230402 is an FDA 510(k) premarket notification submitted by Silk Road Medical for the device "ENROUTE® Transcarotid Neuroprotection System". The FDA issued a decision of Substantially Equivalent on April 11, 2023. The device falls under product code NTE (Temporary Carotid Catheter For Embolic Capture), a Class II device regulated under 21 CFR 870.1250. Silk Road Medical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2023
- Date Received
- February 15, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Carotid Catheter For Embolic Capture
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i