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FDA 510(k)

AIRGUARD VALVED INTRODUCER

K-Number: K042036 · 2004-08-23

ApplicantC.R. Bard, Inc.
Decision Date2004-08-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIRGUARD VALVED INTRODUCER 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 2004-08-23 under 510(k) number K042036. 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 AIRGUARD VALVED INTRODUCER?

AIRGUARD VALVED INTRODUCER is a medical device that received FDA 510(k) clearance on 2004-08-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K042036.

When did AIRGUARD VALVED INTRODUCER receive FDA 510(k) clearance?

AIRGUARD VALVED INTRODUCER received FDA 510(k) clearance on 2004-08-23, under 510(k) number K042036.

Who is the listed applicant for AIRGUARD VALVED INTRODUCER?

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 AIRGUARD VALVED INTRODUCER?

The FDA product code for AIRGUARD VALVED INTRODUCER 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.

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