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FDA 510(k)

ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U

K-Number: K090547 · 2009-03-18

ApplicantC.R. Bard, Inc.
Decision Date2009-03-18
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U 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 2009-03-18 under 510(k) number K090547. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U?

ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U is a medical device that received FDA 510(k) clearance on 2009-03-18. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K090547.

When did ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U receive FDA 510(k) clearance?

ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U received FDA 510(k) clearance on 2009-03-18, under 510(k) number K090547.

Who is the listed applicant for ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U?

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 ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U?

The FDA product code for ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U is NEU.

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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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