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FDA 510(k)

VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH

K-Number: K921352 · 1992-10-26

ApplicantVygon Corp.
Decision Date1992-10-26
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 1992-10-26 under 510(k) number K921352. The device is classified under product code FOS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH?

VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH is a medical device that received FDA 510(k) clearance on 1992-10-26. The listed applicant is Vygon Corp.. The 510(k) number is K921352.

When did VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH receive FDA 510(k) clearance?

VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH received FDA 510(k) clearance on 1992-10-26, under 510(k) number K921352.

Who is the listed applicant for VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH?

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 POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH?

The FDA product code for VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH is FOS.

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Other records listing Vygon Corp. as applicant

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Related Devices (Code: FOS)

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.

K201697Umbilical Vessels CatheterHaolang Medical USA CorporationK130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS KendallK120304FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERFootprint Medical, Inc.K091214FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERFootprint MedicalK091213FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint MedicalK081515NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0Neomed, Inc.

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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