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FDA 510(k)

ARTAIRA Arterial Compression Device (AACD01)

K-Number: K240499 · 2024-10-11

ApplicantAiros Medical, Inc.
Decision Date2024-10-11
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTAIRA Arterial Compression Device (AACD01) is a medical device manufactured by Airos Medical, Inc.. It received FDA 510(k) clearance on 2024-10-11 under approval number K240499. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTAIRA Arterial Compression Device (AACD01)?

ARTAIRA Arterial Compression Device (AACD01) is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Airos Medical, Inc.. The 510(k) number is K240499.

When was ARTAIRA Arterial Compression Device (AACD01) approved by the FDA?

ARTAIRA Arterial Compression Device (AACD01) received FDA 510(k) clearance on 2024-10-11, under approval number K240499.

What company makes ARTAIRA Arterial Compression Device (AACD01)?

ARTAIRA Arterial Compression Device (AACD01) is manufactured by Airos Medical, Inc..

What is the FDA product code for ARTAIRA Arterial Compression Device (AACD01)?

The FDA product code for ARTAIRA Arterial Compression Device (AACD01) is JOW.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT07615738 SpO2 Infant and Pediatric Study NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07305870 Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units ENROLLING_BY_INVITATION NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING

Other Devices by Airos Medical, Inc.

K172779AIROS 8 Sequential Compression Device K172770AIROS 6 Sequential Compression Device K193069AIROS 6 Sequential Compression Device K193068AIROS 8 Sequential Compression Device K223193AIROS 8P Sequential Compression Device K223195AIROS 6P Sequential Compression Device

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Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

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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