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FDA 510(k)

BAG SPIKE EXTENSION SET

K-Number: K863814 · 1986-10-14

ApplicantMed Fusion Systems, Inc.
Decision Date1986-10-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAG SPIKE EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Med Fusion Systems, Inc.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863814. 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 BAG SPIKE EXTENSION SET?

BAG SPIKE EXTENSION SET is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Med Fusion Systems, Inc.. The 510(k) number is K863814.

When did BAG SPIKE EXTENSION SET receive FDA 510(k) clearance?

BAG SPIKE EXTENSION SET received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863814.

Who is the listed applicant for BAG SPIKE EXTENSION SET?

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

What is the FDA product code for BAG SPIKE EXTENSION SET?

The FDA product code for BAG SPIKE EXTENSION SET is FPA.

Related Clinical Trials

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.

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Other records listing Med Fusion Systems, 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.

K873961INFUMED 300 AMBULATORY INFUSION PUMPK870524AMBULATORY INFUSION PUMP DRUG RESERVOIRK870907INTRODUCER, PERCUTANEOUSK864407REFILLABLE SYRINGEK860616VOLUME CONTROL SET WITH EXTENSIONK860803IV FILTER EXTENSION 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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