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Dual Spike Transfer Device

by B. Braun Medical, Inc.

510(k) K120150

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120150 Date24 May 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 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  • Withdrawn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
LHI
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Dual Spike Transfer Device is a medical device used for transferring purposes. It is classified under the product code LHI.

The device is supplied by B. Braun Medical Inc. and has received FDA 510K authorization. It is described as substantially equivalent, with a clearance type of traditional. The device is associated with the k number K120150.

Other devices from B. Braun Medical, Inc.

See all devices from B. Braun Medical, Inc. →

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the Dual Spike Transfer Device used for?

    The Dual Spike Transfer Device is used for transferring purposes, providing a solution for medical transfer needs.

  • Is the Dual Spike Transfer Device sterile?

    The device data does not specify sterility, it is recommended to consult the manufacturer or packaging for this information.

  • What is the regulatory status of the Dual Spike Transfer Device?

    The device has received FDA 510K authorization, classified as substantially equivalent with a traditional clearance type.