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FDA 510(k)

VOLUME CONTROL SET WITH EXTENSION

K-Number: K860616 · 1986-06-02

ApplicantMed Fusion Systems, Inc.
Decision Date1986-06-02
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VOLUME CONTROL SET WITH EXTENSION 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 1986-06-02 under 510(k) number K860616. 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 VOLUME CONTROL SET WITH EXTENSION?

VOLUME CONTROL SET WITH EXTENSION is a medical device that received FDA 510(k) clearance on 1986-06-02. The listed applicant is Med Fusion Systems, Inc.. The 510(k) number is K860616.

When did VOLUME CONTROL SET WITH EXTENSION receive FDA 510(k) clearance?

VOLUME CONTROL SET WITH EXTENSION received FDA 510(k) clearance on 1986-06-02, under 510(k) number K860616.

Who is the listed applicant for VOLUME CONTROL SET WITH EXTENSION?

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 VOLUME CONTROL SET WITH EXTENSION?

The FDA product code for VOLUME CONTROL SET WITH EXTENSION is FPA.

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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 SYRINGEK863814BAG SPIKE EXTENSION SETK860803IV 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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