Cleared Special

ER-REBOA PLUS Catheter

K193440 · Prytime Medical Devices, Inc. · Cardiovascular

Jan 2020

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K193440 is an FDA 510(k) clearance for the ER-REBOA PLUS Catheter, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Prytime Medical Devices, Inc. (Boerne, US). The FDA issued a Cleared decision on January 9, 2020, 29 days after receiving the submission on December 11, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K193440 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2019
Decision Date	January 09, 2020
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF