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FDA 510(k)

Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12

K-Number: K192981 · 2020-05-28

ApplicantPenumbra, Inc.
Decision Date2020-05-28
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K192981. 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 System Aspiration Catheter 12, Indigo Aspiration System Separator 12?

Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Penumbra, Inc.. The 510(k) number is K192981.

When did Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 receive FDA 510(k) clearance?

Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 received FDA 510(k) clearance on 2020-05-28, under 510(k) number K192981.

Who is the listed applicant for Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12?

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 System Aspiration Catheter 12, Indigo Aspiration System Separator 12?

The FDA product code for Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 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)K260599INDIGO® Aspiration System – INDIGO LinkK251949INDIGO® 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)

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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 EndovascularK260599INDIGO® 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.

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