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FDA 510(k)

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS

K-Number: K964238 · 1997-09-08

ApplicantAircast, Inc.
Decision Date1997-09-08
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS is the device name listed in this FDA 510(k) record. The listed applicant is Aircast, Inc.. It received FDA 510(k) clearance on 1997-09-08 under 510(k) number K964238. 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 AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS?

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is Aircast, Inc.. The 510(k) number is K964238.

When did AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS receive FDA 510(k) clearance?

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS received FDA 510(k) clearance on 1997-09-08, under 510(k) number K964238.

Who is the listed applicant for AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS?

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

What is the FDA product code for AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS?

The FDA product code for AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS is JOW.

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Other records listing Aircast, 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.

K024019ARTERIALFLOW SYSTEM, MODEL 32AK023800VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017K992454VENAFLOW SYSTEM, MODEL 30AK961676AIRCAST VENAFLOW SYSTEM (MODIFICATION)K933977AIRCAST EDEMAFLOW SYSTEMK932900AIRCAST VENAFLOW SYSTEM

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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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® 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.

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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