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FDA 510(k)

VYGON DOUBLE LUMEN UMBILICAL CATHETER

K-Number: K981630 · 1998-10-01

ApplicantSchiff & Co.
Decision Date1998-10-01
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VYGON DOUBLE LUMEN UMBILICAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Schiff & Co.. It received FDA 510(k) clearance on 1998-10-01 under 510(k) number K981630. 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 DOUBLE LUMEN UMBILICAL CATHETER?

VYGON DOUBLE LUMEN UMBILICAL CATHETER is a medical device that received FDA 510(k) clearance on 1998-10-01. The listed applicant is Schiff & Co.. The 510(k) number is K981630.

When did VYGON DOUBLE LUMEN UMBILICAL CATHETER receive FDA 510(k) clearance?

VYGON DOUBLE LUMEN UMBILICAL CATHETER received FDA 510(k) clearance on 1998-10-01, under 510(k) number K981630.

Who is the listed applicant for VYGON DOUBLE LUMEN UMBILICAL CATHETER?

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

What is the FDA product code for VYGON DOUBLE LUMEN UMBILICAL CATHETER?

The FDA product code for VYGON DOUBLE LUMEN UMBILICAL CATHETER is FOS.

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Other records listing Schiff & Co. 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.

K990511X-TIP INTRAOSSEOUS PERFORATORK982136JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200K981629NUTRISAFE ENTERAL FEEDING TUBEK974141PLUS REUSABLE RESUSCITATORK954448VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEMK955085HM-CAP EIA TEST (MODIFICATION)

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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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