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FDA 510(k)

INDIGO® Aspiration System – INDIGO Link

K-Number: K260599 · 2026-04-24

ApplicantPenumbra, Inc.
Decision Date2026-04-24
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INDIGO® Aspiration System – INDIGO Link is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260599. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIGO® Aspiration System – INDIGO Link?

INDIGO® Aspiration System – INDIGO Link is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Penumbra, Inc.. The 510(k) number is K260599.

When did INDIGO® Aspiration System – INDIGO Link receive FDA 510(k) clearance?

INDIGO® Aspiration System – INDIGO Link received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260599.

Who is the listed applicant for INDIGO® Aspiration System – INDIGO Link?

The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDIGO® Aspiration System – INDIGO Link?

The FDA product code for INDIGO® Aspiration System – INDIGO Link is QEW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04798261Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration SystemRECRUITINGNCT05003843BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisACTIVE_NOT_RECRUITINGNCT05684796Comparison of Two Pulmonary Embolism TreatmentsCOMPLETEDNCT05437055THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration TubingCOMPLETEDNCT06747117A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)RECRUITINGNCT07107022Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).RECRUITING

Other records listing Penumbra, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250690Penumbra System (Thunderbolt Aspiration Tubing)K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKK252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingK250079Ruby XL SystemK242104Penumbra System (Reperfusion Catheter RED 72)K242033Access25™ Delivery Microcatheter

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Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular CorporationK252956Helo Thrombectomy SystemEndovascular Engineering, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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