510(k) clearance
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- 510(k) number
- K263266
- Applicant
- Route 92 Medical, Inc.
- Decision date
- Oct 16, 2026
- Date received
- Sep 18, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- NRY
- Device type
- Catheter, Thrombus Retriever
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- San Mateo, CA, US