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FDA 510(k)

USCI GRUNTZIG DILACA BALLOON DILATION

K-Number: K830608 · 1983-03-24

ApplicantC.R. Bard, Inc.
Decision Date1983-03-24
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

USCI GRUNTZIG DILACA BALLOON DILATION 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 1983-03-24 under 510(k) number K830608. 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 USCI GRUNTZIG DILACA BALLOON DILATION?

USCI GRUNTZIG DILACA BALLOON DILATION is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K830608.

When did USCI GRUNTZIG DILACA BALLOON DILATION receive FDA 510(k) clearance?

USCI GRUNTZIG DILACA BALLOON DILATION received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830608.

Who is the listed applicant for USCI GRUNTZIG DILACA BALLOON DILATION?

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 GRUNTZIG DILACA BALLOON DILATION?

The FDA product code for USCI GRUNTZIG DILACA BALLOON DILATION is LIT.

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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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