Cleared Traditional

Occlusion Balloon Catheter

K142692 · Embolx, Inc. · Cardiovascular

May 2015

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K142692 is an FDA 510(k) clearance for the Occlusion Balloon Catheter, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Embolx, Inc. (Los Altos, US). The FDA issued a Cleared decision on May 31, 2015, 251 days after receiving the submission on September 22, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K142692 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2014
Decision Date	May 31, 2015
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF