Cleared Traditional

AortaSTAT Occlusion Device

K210602 · Renalpro Medical, Inc. · Cardiovascular

Jul 2021

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K210602 is an FDA 510(k) clearance for the AortaSTAT Occlusion Device, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Renalpro Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 9, 2021, 130 days after receiving the submission on March 1, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K210602 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2021
Decision Date	July 09, 2021
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF