Cleared Traditional

LANDMARK REBOA Catheter

K214060 · Zien Medical Technologies, Inc. · Cardiovascular

Sep 2022

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K214060 is an FDA 510(k) clearance for the LANDMARK REBOA Catheter, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Zien Medical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 2022, 266 days after receiving the submission on December 27, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K214060 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2021
Decision Date	September 19, 2022
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF