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Cardioplegia Recirculation Sys-Bl 705/A

by Electromedics, Inc.

510(k) K831458

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831458 Date20 Oct 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWB
Device Class
Class II
Regulation
21 CFR Part 870.4370
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardioplegia Recirculation System BL 705/A is a Pump, Blood, Cardiopulmonary Bypass, Roller Type, designed for cardioplegia delivery during cardiac surgical procedures. It circulates and recirculates cardioplegic solution to protect the myocardium during periods of cardiac arrest, ensuring oxygenated blood delivery to the heart tissue.

This system is intended for use in operating rooms during cardiovascular surgeries and is supplied as a reusable medical device. It is classified as a Class II device under FDA regulations (21 CFR 870.4370) and holds an FDA 510(k) clearance (K831458) with a traditional review pathway. No specific sterility or MRI safety information is provided in the available data.

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