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FDA 510(k)

SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

K-Number: K011916 · 2001-10-31

ApplicantHorizon Medical Products, Inc.
Decision Date2001-10-31
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES 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 2001-10-31 under 510(k) number K011916. 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 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES?

SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES is a medical device that received FDA 510(k) clearance on 2001-10-31. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K011916.

When did SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES receive FDA 510(k) clearance?

SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES received FDA 510(k) clearance on 2001-10-31, under 510(k) number K011916.

Who is the listed applicant for SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES?

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 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES?

The FDA product code for SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES is MSD.

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Related Devices (Code: MSD)

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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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