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FDA 510(k)

BALLOON THERMODILUTION CATHETER #7164&

K-Number: K823433 · 1982-11-30

ApplicantCritikon Company, LLC
Decision Date1982-11-30
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BALLOON THERMODILUTION CATHETER #7164& is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1982-11-30 under 510(k) number K823433. 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 BALLOON THERMODILUTION CATHETER #7164&?

BALLOON THERMODILUTION CATHETER #7164& is a medical device that received FDA 510(k) clearance on 1982-11-30. The listed applicant is Critikon Company, LLC. The 510(k) number is K823433.

When did BALLOON THERMODILUTION CATHETER #7164& receive FDA 510(k) clearance?

BALLOON THERMODILUTION CATHETER #7164& received FDA 510(k) clearance on 1982-11-30, under 510(k) number K823433.

Who is the listed applicant for BALLOON THERMODILUTION CATHETER #7164&?

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

What is the FDA product code for BALLOON THERMODILUTION CATHETER #7164&?

The FDA product code for BALLOON THERMODILUTION CATHETER #7164& is DYG.

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Other records listing Critikon Company, LLC as applicant

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Related Devices (Code: DYG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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