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FDA 510(k)

USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING

K-Number: K915553 · 1992-02-21

ApplicantC.R. Bard, Inc.
Decision Date1992-02-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING 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 1992-02-21 under 510(k) number K915553. 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) HEMAFLEX(TM) INTRODUCER WITH COATING?

USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING is a medical device that received FDA 510(k) clearance on 1992-02-21. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K915553.

When did USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING receive FDA 510(k) clearance?

USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING received FDA 510(k) clearance on 1992-02-21, under 510(k) number K915553.

Who is the listed applicant for USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING?

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) HEMAFLEX(TM) INTRODUCER WITH COATING?

The FDA product code for USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING 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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