510(k) K263266
K263266 is an FDA 510(k) premarket notification submitted by Route 92 Medical, Inc. for the device "Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code NRY (Catheter, Thrombus Retriever), a Class II device regulated under 21 CFR 870.1250. Route 92 Medical, Inc. has 15 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2026
- Date Received
- Sep 18, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Thrombus Retriever
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- NE
- Submission Type
- 510(k)
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.