INDIGO® Aspiration System INDIGO Link— 510(k) K260599
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K260599 for INDIGO® Aspiration System INDIGO Link, Substantially Equivalent on 2026-04-24. Applicant: Penumbra, Inc.. Device class: 2.
Summary
Penumbra's record gives the device name as INDIGO Aspiration System INDIGO Link, filed under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration). The record doesn't describe it beyond that name and the code name.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Penumbra filed from Alameda, California. The decision came 59 calendar days after FDA received it (February 24 to April 24, 2026).
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Product code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code QEW
view allMore clearances from Penumbra, Inc.
view all- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K250079 — Ruby XL System
- K242104 — Penumbra System (Reperfusion Catheter RED 72)
Adverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.