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FDA 510(k)

ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS

K-Number: K093965 · 2010-03-17

ApplicantC.R. Bard, Inc.
Decision Date2010-03-17
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS 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 2010-03-17 under 510(k) number K093965. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS?

ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS is a medical device that received FDA 510(k) clearance on 2010-03-17. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K093965.

When did ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS receive FDA 510(k) clearance?

ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS received FDA 510(k) clearance on 2010-03-17, under 510(k) number K093965.

Who is the listed applicant for ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS?

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 ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS?

The FDA product code for ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS is LIT.

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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.

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