510(k) clearance

INDIGO® Aspiration System

FDA 510(k) source

510(k) number

K262904

Applicant

Penumbra, Inc.

Decision date

Oct 15, 2026

Date received

Aug 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QEW

Device type

Peripheral Mechanical Thrombectomy With Aspiration

Device class

Class II

Regulation

21 CFR 870.5150

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Alameda, CA, US