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Medtronic Bio-Medicus Handcrank Model 150

by Medtronic Bio-Medicus, Inc.

510(k) K926357

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926357 Date2 Jun 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DWA
Device Class
Class II
Regulation
21 CFR Part 870.4380
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 Medtronic Bio-Medicus Handcrank Model 150 is a manual drive unit designed for use with Bio-Medicus centrifugal blood pump systems. It provides a reliable means of maintaining pump function in the event of a power failure or primary drive unit malfunction during cardiopulmonary bypass procedures.

This device serves as a critical backup component in cardiac surgery settings. It is supplied as a reusable manual drive unit and was authorized via FDA 510(k) clearance K926357, with product code DWA and regulation number 870.4380, classified as a Class II device for cardiovascular use.

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