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FDA 510(k)

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR

K-Number: K963571 · 1997-06-02

ApplicantVygon Corp.
Decision Date1997-06-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 1997-06-02 under 510(k) number K963571. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR?

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR is a medical device that received FDA 510(k) clearance on 1997-06-02. The listed applicant is Vygon Corp.. The 510(k) number is K963571.

When did VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR receive FDA 510(k) clearance?

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR received FDA 510(k) clearance on 1997-06-02, under 510(k) number K963571.

Who is the listed applicant for VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR?

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 MULTI-DOSE VIAL ADAPTER & BIONECTOR?

The FDA product code for VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR is FMI.

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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: FMI)

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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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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