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FDA 510(k)

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

K-Number: K101843 · 2010-10-20

ApplicantAngioDynamics, Inc.
Decision Date2010-10-20
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2010-10-20 under 510(k) number K101843. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT?

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2010-10-20. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K101843.

When did DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT receive FDA 510(k) clearance?

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT received FDA 510(k) clearance on 2010-10-20, under 510(k) number K101843.

Who is the listed applicant for DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT?

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

What is the FDA product code for DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT?

The FDA product code for DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is 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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