Cleared Traditional

ER-REBOA Catheter

K170411 · Prytime Medical Devices, Inc. · Cardiovascular

Apr 2017

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K170411 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 April 4, 2017, 53 days after receiving the submission on February 10, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K170411 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2017
Decision Date	April 04, 2017
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF