Cleared Traditional

K170223 - Progreat (FDA 510(k) Clearance)

K170223 · Ashitaka Factory of Terumo Corporation · Cardiovascular device

Jul 2017

Decision

177d

Days

Class 2

Risk

K170223 is an FDA 510(k) clearance for the Progreat. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).

Submitted by Ashitaka Factory of Terumo Corporation (Fujinomiya, JP). The FDA issued a Cleared decision on July 21, 2017, 177 days after receiving the submission on January 25, 2017.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K170223 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 25, 2017
Decision Date	July 21, 2017
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF