Blood Reservoir

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770546 ↗

FDA Product Code

DTN

Device Class

Class II

Regulation

21 CFR Part 870.4400

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class I

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  Class II

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  Class II

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  Class II

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  Class II

  FDA 510(k) K830389 Active Cleared 12 Sep 1983

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  Class II

  FDA 510(k) K822761 Active Cleared 30 Sep 1982

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