FDA 510(k)

BARD DIRECTOR GUIDEWIRE (000560)

K-Number: K964780 · 1997-02-26

Decision Date1997-02-26

Product CodeOCY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BARD DIRECTOR GUIDEWIRE (000560) 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 1997-02-26 under 510(k) number K964780. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD DIRECTOR GUIDEWIRE (000560)?

BARD DIRECTOR GUIDEWIRE (000560) is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K964780.

When did BARD DIRECTOR GUIDEWIRE (000560) receive FDA 510(k) clearance?

BARD DIRECTOR GUIDEWIRE (000560) received FDA 510(k) clearance on 1997-02-26, under 510(k) number K964780.

Who is the listed applicant for BARD DIRECTOR GUIDEWIRE (000560)?

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 BARD DIRECTOR GUIDEWIRE (000560)?

The FDA product code for BARD DIRECTOR GUIDEWIRE (000560) is OCY.

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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.