FDA 510(k)

CATHETER, GRUNTZIG, BALLON

K-Number: K770522 · 1977-03-30

Decision Date1977-03-30

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CATHETER, GRUNTZIG, BALLON is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770522. 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, GRUNTZIG, BALLON?

CATHETER, GRUNTZIG, BALLON is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Cook, Inc.. The 510(k) number is K770522.

When did CATHETER, GRUNTZIG, BALLON receive FDA 510(k) clearance?

CATHETER, GRUNTZIG, BALLON received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770522.

Who is the listed applicant for CATHETER, GRUNTZIG, BALLON?

The FDA 510(k) record lists Cook, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER, GRUNTZIG, BALLON?

The FDA product code for CATHETER, GRUNTZIG, BALLON is DYG.

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Other records listing Cook, Inc. as applicant

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Related Devices (Code: DYG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.