INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK— 510(k) K251949
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K251949 for INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK, Substantially Equivalent on 2026-02-05. Applicant: Penumbra, Inc.. Device class: 2.
Summary
Penumbra's INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK is filed under product code QEW, peripheral mechanical thrombectomy with aspiration. The record doesn't describe the tubing beyond its name and that code name.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Penumbra filed from Alameda, California. FDA found it substantially equivalent 225 calendar days after receipt (June 25, 2025 to February 5, 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)
- K260599 — INDIGO® Aspiration System INDIGO 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.