Cleared Traditional

ER-REBOA Catheter

K172790 · Prytime Medical Devices, Inc. · Cardiovascular

Nov 2017

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K172790 is an FDA 510(k) clearance for the ER-REBOA 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 November 8, 2017, 54 days after receiving the submission on September 15, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K172790 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2017
Decision Date	November 08, 2017
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF