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FDA 510(k)

CATHETER, USCI GRUNTZIG/BALLOON

K-Number: K782071 · 1978-12-15

ApplicantC.R. Bard, Inc.
Decision Date1978-12-15
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, USCI GRUNTZIG/BALLOON 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 1978-12-15 under 510(k) number K782071. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, USCI GRUNTZIG/BALLOON?

CATHETER, USCI GRUNTZIG/BALLOON is a medical device that received FDA 510(k) clearance on 1978-12-15. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K782071.

When did CATHETER, USCI GRUNTZIG/BALLOON receive FDA 510(k) clearance?

CATHETER, USCI GRUNTZIG/BALLOON received FDA 510(k) clearance on 1978-12-15, under 510(k) number K782071.

Who is the listed applicant for CATHETER, USCI GRUNTZIG/BALLOON?

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 CATHETER, USCI GRUNTZIG/BALLOON?

The FDA product code for CATHETER, USCI GRUNTZIG/BALLOON is DYG.

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Related Devices (Code: DYG)

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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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