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FDA 510(k)

Excipio SV Aspiration Catheter and Tubing

K-Number: K230030 · 2023-05-30

ApplicantContego Medical, Inc.
Decision Date2023-05-30
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Excipio SV Aspiration Catheter and Tubing is a medical device manufactured by Contego Medical, Inc.. It received FDA 510(k) clearance on 2023-05-30 under approval number K230030. 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 Excipio SV Aspiration Catheter and Tubing?

Excipio SV Aspiration Catheter and Tubing is a medical device that received FDA 510(k) clearance on 2023-05-30. It is manufactured by Contego Medical, Inc.. The 510(k) number is K230030.

When was Excipio SV Aspiration Catheter and Tubing approved by the FDA?

Excipio SV Aspiration Catheter and Tubing received FDA 510(k) clearance on 2023-05-30, under approval number K230030.

What company makes Excipio SV Aspiration Catheter and Tubing?

Excipio SV Aspiration Catheter and Tubing is manufactured by Contego Medical, Inc..

What is the FDA product code for Excipio SV Aspiration Catheter and Tubing?

The FDA product code for Excipio SV Aspiration Catheter and Tubing is QEW.

Related Clinical Trials

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Other Devices by Contego Medical, Inc.

K221204Excipio SV Thrombectomy Device K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection K223897Excipio LV Thrombectomy Device K251485Excipio LV Prime Thrombectomy Device PMA P240009Stent, carotid

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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