FDA 510(k)

VACCESS PTA DILATATION CATHETER

K-Number: K111850 · 2011-07-13

Decision Date2011-07-13

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VACCESS PTA DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2011-07-13 under 510(k) number K111850. 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 VACCESS PTA DILATATION CATHETER?

VACCESS PTA DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-07-13. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K111850.

When did VACCESS PTA DILATATION CATHETER receive FDA 510(k) clearance?

VACCESS PTA DILATATION CATHETER received FDA 510(k) clearance on 2011-07-13, under 510(k) number K111850.

Who is the listed applicant for VACCESS PTA DILATATION CATHETER?

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

What is the FDA product code for VACCESS PTA DILATATION CATHETER?

The FDA product code for VACCESS PTA DILATATION CATHETER is 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.