Cleared Traditional

Altrix Precision Temperature Management System

K180834 · Stryker Medical · Cardiovascular

Aug 2018

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K180834 is an FDA 510(k) clearance for the Altrix Precision Temperature Management System, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on August 10, 2018, 133 days after receiving the submission on March 30, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K180834 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2018
Decision Date	August 10, 2018
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5900
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).