510(k) clearance

Route 92 Medical Full Length 046 Access System

FDA 510(k) source

510(k) number

K260220

Applicant

Route 92 Medical, Inc.

Decision date

Sep 16, 2026

Date received

Jan 26, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QJP

Device type

Catheter, Percutaneous, Neurovasculature

Device class

Class II

Regulation

21 CFR 870.1250

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

San Mateo, CA, US