FDA 510(k)

Pinpoint GT Introducer Needle

K-Number: K162769 · 2016-11-04

Decision Date2016-11-04

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Pinpoint GT Introducer Needle 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 2016-11-04 under 510(k) number K162769. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pinpoint GT Introducer Needle?

Pinpoint GT Introducer Needle is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K162769.

When did Pinpoint GT Introducer Needle receive FDA 510(k) clearance?

Pinpoint GT Introducer Needle received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162769.

Who is the listed applicant for Pinpoint GT Introducer Needle?

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 Pinpoint GT Introducer Needle?

The FDA product code for Pinpoint GT Introducer Needle is DYB.

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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.