Flowtron ACS900— 510(k) K143438

Substantially Equivalent

Getinge (Suzhou) Co., Ltd.

FDA 510(k) clearance K143438 for Flowtron ACS900, Substantially Equivalent on 2015-06-23. Applicant: Getinge (Suzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Getinge (Suzhou) Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2014-12-02
Decision date: 2015-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, TW

Download summary PDF View on FDA.gov ↗

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Recalls naming K143438

K-number listed on FDA's recall record

Z-2714-2017 — ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.Class II·Terminated·Arjo, Inc. dba ArjoHuntleigh·20170614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143438.

Data sourced from openFDA. This site is unofficial and independent of the FDA.