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FDA 510(k)

072 Aspiration System

K-Number: K222786 · 2023-08-25

ApplicantQ'Apel Medical, Inc.
Decision Date2023-08-25
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

072 Aspiration System is a medical device manufactured by Q'Apel Medical, Inc.. It received FDA 510(k) clearance on 2023-08-25 under approval number K222786. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 072 Aspiration System?

072 Aspiration System is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Q'Apel Medical, Inc.. The 510(k) number is K222786.

When was 072 Aspiration System approved by the FDA?

072 Aspiration System received FDA 510(k) clearance on 2023-08-25, under approval number K222786.

What company makes 072 Aspiration System?

072 Aspiration System is manufactured by Q'Apel Medical, Inc..

What is the FDA product code for 072 Aspiration System?

The FDA product code for 072 Aspiration System is NRY.

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 Q'Apel Medical, Inc.

K211893SelectFlex Neurovascular Access System Family K230322SelectFlex Neurovascular Access System Family K240746Neurovascular Access System Family

Related Devices (Code: NRY)

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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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