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.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- 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 all- K261800 — Helo Max Thrombectomy System (HEL2090)
- K262538 — Artix MT; Artix Thin-Walled Sheath
- K261523 — Vertex Thrombectomy System
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
More clearances from Penumbra, Inc.
view all- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- 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)
- K242033 — Access25 Delivery Microcatheter
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.