FDA 510(k)

ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

K-Number: K101017 · 2010-06-17

Decision Date2010-06-17

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2010-06-17 under 510(k) number K101017. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS?

ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-06-17. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K101017.

When did ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS receive FDA 510(k) clearance?

ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS received FDA 510(k) clearance on 2010-06-17, under 510(k) number K101017.

Who is the listed applicant for ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS?

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 ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS?

The FDA product code for ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS is LJT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.