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FDA 510(k)

USCI ANGIOGRAPHIC BALLOON CATHETER

K-Number: K831854 · 1983-10-20

ApplicantC.R. Bard, Inc.
Decision Date1983-10-20
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

USCI ANGIOGRAPHIC BALLOON CATHETER 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 1983-10-20 under 510(k) number K831854. 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 USCI ANGIOGRAPHIC BALLOON CATHETER?

USCI ANGIOGRAPHIC BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K831854.

When did USCI ANGIOGRAPHIC BALLOON CATHETER receive FDA 510(k) clearance?

USCI ANGIOGRAPHIC BALLOON CATHETER received FDA 510(k) clearance on 1983-10-20, under 510(k) number K831854.

Who is the listed applicant for USCI ANGIOGRAPHIC BALLOON CATHETER?

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 ANGIOGRAPHIC BALLOON CATHETER?

The FDA product code for USCI ANGIOGRAPHIC BALLOON CATHETER 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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