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FDA 510(k)

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

K-Number: K965214 · 1997-03-28

ApplicantCoeur Laboratories, Inc.
Decision Date1997-03-28
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) 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 1997-03-28 under 510(k) number K965214. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)?

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K965214.

When did COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) receive FDA 510(k) clearance?

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) received FDA 510(k) clearance on 1997-03-28, under 510(k) number K965214.

Who is the listed applicant for COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)?

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 COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)?

The FDA product code for COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) is DTX.

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Other records listing Coeur Laboratories, Inc. as applicant

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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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