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FDA 510(k)

INFUSION PORT BALLOON THERMODILUTION

K-Number: K833918 · 1984-01-30

ApplicantCritikon Company, LLC
Decision Date1984-01-30
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFUSION PORT BALLOON THERMODILUTION 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 1984-01-30 under 510(k) number K833918. 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 INFUSION PORT BALLOON THERMODILUTION?

INFUSION PORT BALLOON THERMODILUTION is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Critikon Company, LLC. The 510(k) number is K833918.

When did INFUSION PORT BALLOON THERMODILUTION receive FDA 510(k) clearance?

INFUSION PORT BALLOON THERMODILUTION received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833918.

Who is the listed applicant for INFUSION PORT BALLOON THERMODILUTION?

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 INFUSION PORT BALLOON THERMODILUTION?

The FDA product code for INFUSION PORT BALLOON THERMODILUTION 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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