Cleared Traditional

BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET

K900186 · Shiley, Inc. · Cardiovascular

Apr 1990

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K900186 is an FDA 510(k) clearance for the BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on April 10, 1990, 84 days after receiving the submission on January 16, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K900186 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1990
Decision Date	April 10, 1990
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

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).