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FDA 510(k)

VYGON BIONECTOR WITH EXTENSION SET

K-Number: K963981 · 1997-02-14

ApplicantVygon Corp.
Decision Date1997-02-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VYGON BIONECTOR WITH EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K963981. 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 VYGON BIONECTOR WITH EXTENSION SET?

VYGON BIONECTOR WITH EXTENSION SET is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Vygon Corp.. The 510(k) number is K963981.

When did VYGON BIONECTOR WITH EXTENSION SET receive FDA 510(k) clearance?

VYGON BIONECTOR WITH EXTENSION SET received FDA 510(k) clearance on 1997-02-14, under 510(k) number K963981.

Who is the listed applicant for VYGON BIONECTOR WITH EXTENSION SET?

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

What is the FDA product code for VYGON BIONECTOR WITH EXTENSION SET?

The FDA product code for VYGON BIONECTOR WITH EXTENSION SET is FPA.

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Other records listing Vygon Corp. 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.

K121105NUTRISAFE 2 FEEDING TUBEK100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXK073493HEPATOSTAT SETK070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039K061796HEPATOSTAT SET, MODEL 760XK061250MULTICATH EXPERT

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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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