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FDA 510(k)

LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER

K-Number: K022905 · 2002-12-13

ApplicantHorizon Medical Products, Inc.
Decision Date2002-12-13
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Medical Products, Inc.. It received FDA 510(k) clearance on 2002-12-13 under 510(k) number K022905. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER?

LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER is a medical device that received FDA 510(k) clearance on 2002-12-13. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K022905.

When did LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER receive FDA 510(k) clearance?

LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER received FDA 510(k) clearance on 2002-12-13, under 510(k) number K022905.

Who is the listed applicant for LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER?

The FDA 510(k) record lists Horizon Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER?

The FDA product code for LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER is MSD.

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Other records listing Horizon Medical Products, 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.

K033473MODIFICATION TO VORTEX MP VASCULAR ACCESS PORTK032754VORTEX MPK032557TRIUMPH VTX WITH LIFEVALVE CATHETERK031718LIFEVALVE CENTRAL VENOUS CATHTERK013871LIFEGUARD SAFETY INFUSION SETK011916SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

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Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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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