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)

HIGH FLOW I.V. SET

K-Number: K861275 · 1986-06-02

ApplicantMigada, Ltd.
Decision Date1986-06-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HIGH FLOW I.V. SET is the device name listed in this FDA 510(k) record. The listed applicant is Migada, Ltd.. It received FDA 510(k) clearance on 1986-06-02 under 510(k) number K861275. 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 HIGH FLOW I.V. SET?

HIGH FLOW I.V. SET is a medical device that received FDA 510(k) clearance on 1986-06-02. The listed applicant is Migada, Ltd.. The 510(k) number is K861275.

When did HIGH FLOW I.V. SET receive FDA 510(k) clearance?

HIGH FLOW I.V. SET received FDA 510(k) clearance on 1986-06-02, under 510(k) number K861275.

Who is the listed applicant for HIGH FLOW I.V. SET?

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 HIGH FLOW I.V. SET?

The FDA product code for HIGH FLOW I.V. SET is FPA.

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

View all 15 devices →

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.

↑