FDA 510(k)

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

K-Number: K160533 · 2016-05-24

Decision Date2016-05-24

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) number K160533. 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 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is a medical device that received FDA 510(k) clearance on 2016-05-24. The listed applicant is Penumbra, Inc.. The 510(k) number is K160533.

When did Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) receive FDA 510(k) clearance?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) received FDA 510(k) clearance on 2016-05-24, under 510(k) number K160533.

Who is the listed applicant for Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

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 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

The FDA product code for Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) 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 SystemRECRUITING NCT05437055THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration TubingCOMPLETED NCT06747117A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)RECRUITING NCT05003843BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisACTIVE_NOT_RECRUITING NCT05684796Comparison of Two Pulmonary Embolism TreatmentsCOMPLETED NCT07107022Study 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

K250690Penumbra System (Thunderbolt Aspiration Tubing)K260599INDIGO® Aspiration System – INDIGO Link K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing K250079Ruby XL System K242104Penumbra System (Reperfusion Catheter RED 72)

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Related Devices (Code: QEW)

K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ 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 Corporation

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.