510(k) clearance

APRO 88 Catheter

FDA 510(k) source

510(k) number

K261938

Applicant

Alembic, LLC

Decision date

Oct 6, 2026

Date received

Jun 10, 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

Mountain View, CA, US