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FDA 510(k)

ANGIODYNAMICS PROFILER PTA BALLOON CATHETER

K-Number: K051060 · 2005-05-26

ApplicantAngioDynamics, Inc.
Decision Date2005-05-26
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS PROFILER PTA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K051060. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIODYNAMICS PROFILER PTA BALLOON CATHETER?

ANGIODYNAMICS PROFILER PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K051060.

When did ANGIODYNAMICS PROFILER PTA BALLOON CATHETER receive FDA 510(k) clearance?

ANGIODYNAMICS PROFILER PTA BALLOON CATHETER received FDA 510(k) clearance on 2005-05-26, under 510(k) number K051060.

Who is the listed applicant for ANGIODYNAMICS PROFILER PTA BALLOON CATHETER?

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 PROFILER PTA BALLOON CATHETER?

The FDA product code for ANGIODYNAMICS PROFILER PTA BALLOON CATHETER is DQY.

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Related Devices (Code: DQY)

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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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