Cleared Traditional

K892446 - SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
(FDA 510(k) Clearance)

K892446 · Shiley, Inc. · Cardiovascular

Jul 1989

Decision

95d

Days

Class 2

Risk

K892446 is an FDA 510(k) clearance for the SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 14, 1989, 95 days after receiving the submission on April 10, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number	K892446 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1989
Decision Date	July 14, 1989
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—