Bioport Closed Blood Sampling System, Model BT XXXXXX- BP

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K983372 ↗

FDA Product Code

DRS

Device Class

Class II

Regulation

21 CFR Part 870.2850

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Bioport Closed Blood Sampling System BT XXXXXX-BP used for?

  The Bioport Closed Blood Sampling System Model BT XXXXXX-BP is a transducer designed for extravascular blood-pressure monitoring in cardiovascular applications, as indicated by its product code DRS and regulation number 870.2850.

• How is the Bioport Closed Blood Sampling System BT XXXXXX-BP supplied and is it reusable?

  The device is supplied as a single unit and is intended for single use in clinical settings, based on its description as a single-unit extravascular blood-pressure transducer with no mention of reprocessing or reuse.

• What regulatory pathway was used for the Bioport Closed Blood Sampling System BT XXXXXX-BP?

  The device received FDA 510(k) clearance on February 5, 1999, under submission K983372, determined to be substantially equivalent to a predicate device.