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FDA 510(k)

CRITIKON HEPARIN-COATED CARDIOVASCULAR

K-Number: K843141 · 1984-09-04

ApplicantCritikon Company, LLC
Decision Date1984-09-04
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKON HEPARIN-COATED CARDIOVASCULAR 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 1984-09-04 under 510(k) number K843141. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIKON HEPARIN-COATED CARDIOVASCULAR?

CRITIKON HEPARIN-COATED CARDIOVASCULAR is a medical device that received FDA 510(k) clearance on 1984-09-04. The listed applicant is Critikon Company, LLC. The 510(k) number is K843141.

When did CRITIKON HEPARIN-COATED CARDIOVASCULAR receive FDA 510(k) clearance?

CRITIKON HEPARIN-COATED CARDIOVASCULAR received FDA 510(k) clearance on 1984-09-04, under 510(k) number K843141.

Who is the listed applicant for CRITIKON HEPARIN-COATED CARDIOVASCULAR?

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 CRITIKON HEPARIN-COATED CARDIOVASCULAR?

The FDA product code for CRITIKON HEPARIN-COATED CARDIOVASCULAR is LDF.

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Related Devices (Code: LDF)

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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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