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

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 the device name listed in this FDA 510(k) record. The listed applicant is Airos Medical, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) 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. The listed applicant is Airos Medical, Inc.. The 510(k) number is K240499.

When did ARTAIRA Arterial Compression Device (AACD01) receive FDA 510(k) clearance?

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

Who is the listed applicant for ARTAIRA Arterial Compression Device (AACD01)?

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

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

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

Other records listing Airos 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.

K223195AIROS 6P Sequential Compression DeviceK223193AIROS 8P Sequential Compression DeviceK193069AIROS 6 Sequential Compression DeviceK193068AIROS 8 Sequential Compression DeviceK172779AIROS 8 Sequential Compression DeviceK172770AIROS 6 Sequential Compression Device

View all 7 devices →

Related Devices (Code: JOW)

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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

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.

↑