FDA 510(k)

COEURLOCK STERILE DISPOS. ANGIOGRAPHIC

K-Number: K823920 · 1983-02-18

Decision Date1983-02-18

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COEURLOCK STERILE DISPOS. ANGIOGRAPHIC is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Laboratories, Inc.. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K823920. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COEURLOCK STERILE DISPOS. ANGIOGRAPHIC?

COEURLOCK STERILE DISPOS. ANGIOGRAPHIC is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K823920.

When did COEURLOCK STERILE DISPOS. ANGIOGRAPHIC receive FDA 510(k) clearance?

COEURLOCK STERILE DISPOS. ANGIOGRAPHIC received FDA 510(k) clearance on 1983-02-18, under 510(k) number K823920.

Who is the listed applicant for COEURLOCK STERILE DISPOS. ANGIOGRAPHIC?

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

What is the FDA product code for COEURLOCK STERILE DISPOS. ANGIOGRAPHIC?

The FDA product code for COEURLOCK STERILE DISPOS. ANGIOGRAPHIC is DXT.

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Other records listing Coeur Laboratories, Inc. as applicant

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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.