Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

K-Number: K193595 · 2020-08-19

ApplicantPenumbra, Inc.
Decision Date2020-08-19
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2020-08-19 under approval number K193595. 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 - Aspiration Catheter 7 and Separator 7?

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Penumbra, Inc.. The 510(k) number is K193595.

When was Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 approved by the FDA?

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 received FDA 510(k) clearance on 2020-08-19, under approval number K193595.

What company makes Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 is manufactured by Penumbra, Inc..

What is the FDA product code for Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

The FDA product code for Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 is QEW.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) 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.

↑