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FDA 510(k)

I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT

K-Number: K853385 · 1985-08-23

ApplicantMigada, Ltd.
Decision Date1985-08-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT is the device name listed in this FDA 510(k) record. The listed applicant is Migada, Ltd.. It received FDA 510(k) clearance on 1985-08-23 under 510(k) number K853385. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT?

I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT is a medical device that received FDA 510(k) clearance on 1985-08-23. The listed applicant is Migada, Ltd.. The 510(k) number is K853385.

When did I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT receive FDA 510(k) clearance?

I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT received FDA 510(k) clearance on 1985-08-23, under 510(k) number K853385.

Who is the listed applicant for I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT?

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

What is the FDA product code for I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT?

The FDA product code for I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT is FPA.

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Other records listing Migada, Ltd. 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.

K943095IV TRANSFER SPIKEK933929LAB-SITE(R) SAFETY CANNULAK902881LAB-SITE SAFETY NEEDLEK870016ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)K864453EMERGENCY & MILITARY INFUSION SYSTEMK863304PRESELECTED FLOW RATE I.V. SET

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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