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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 the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical, Inc.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) 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. The listed applicant is Q'Apel Medical, Inc.. The 510(k) number is K222786.

When did 072 Aspiration System receive FDA 510(k) clearance?

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

Who is the listed applicant for 072 Aspiration System?

The FDA 510(k) record lists Q'Apel Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 072 Aspiration System?

The FDA product code for 072 Aspiration System is NRY.

Other records listing Q'Apel Medical, 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.

K254276Lynx Aspiration Catheter SystemK240746Neurovascular Access System FamilyK230322SelectFlex Neurovascular Access System FamilyK211893SelectFlex Neurovascular Access System FamilyK192525087 Balloon Guide Catheter SystemK191664SelectFlex 072 Neurovascular Access System

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Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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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