Coeur Front Load Injector Retrofit Kit (C859-0002)

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K965214 ↗

FDA Product Code

DTX

Device Class

Class II

Regulation

21 CFR Part 870.4300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K960965 Active Cleared 12 Sep 1996

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  FDA 510(k) K971712 Active Cleared 8 Oct 1997

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