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FDA 510(k)

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing

K-Number: K252612 · 2025-10-16

ApplicantPenumbra, Inc.
Decision Date2025-10-16
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2025-10-16 under approval number K252612. 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 – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing?

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Penumbra, Inc.. The 510(k) number is K252612.

When was INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing approved by the FDA?

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing received FDA 510(k) clearance on 2025-10-16, under approval number K252612.

What company makes INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing?

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing is manufactured by Penumbra, Inc..

What is the FDA product code for INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing?

The FDA product code for INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

View all 59 devices →

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, 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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