510(k) K262021
K262021 is an FDA 510(k) premarket notification submitted by Toro Neurovascular, Inc. for the device "Toro 71 Aspiration Catheter; Toro Aspiration Tubing". The FDA issued a decision of Substantially Equivalent on Oct 21, 2026. The device falls under product code NRY (Catheter, Thrombus Retriever), a Class II device regulated under 21 CFR 870.1250. Toro Neurovascular, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2026
- Date Received
- Jun 16, 2026
- Clearance Type
- Traditional
- 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.