Cleared Special

K010338 - ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
(FDA 510(k) Clearance)

K010338 · Medivance, Inc. · Cardiovascular

Mar 2001

Decision

30d

Days

Class 2

Risk

K010338 is an FDA 510(k) clearance for the ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on March 7, 2001, 30 days after receiving the submission on February 5, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K010338 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2001
Decision Date	March 07, 2001
Days to Decision	30 days
Submission Type	Special
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).