FDA 510(k)

USCI(R) ACCESS(TM) INTRODUCER SET

K-Number: K901452 · 1990-05-22

Decision Date1990-05-22

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

USCI(R) ACCESS(TM) INTRODUCER SET 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 1990-05-22 under 510(k) number K901452. 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 USCI(R) ACCESS(TM) INTRODUCER SET?

USCI(R) ACCESS(TM) INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K901452.

When did USCI(R) ACCESS(TM) INTRODUCER SET receive FDA 510(k) clearance?

USCI(R) ACCESS(TM) INTRODUCER SET received FDA 510(k) clearance on 1990-05-22, under 510(k) number K901452.

Who is the listed applicant for USCI(R) ACCESS(TM) INTRODUCER SET?

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 USCI(R) ACCESS(TM) INTRODUCER SET?

The FDA product code for USCI(R) ACCESS(TM) INTRODUCER SET is DYB.

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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.