Cleared Traditional

K180831 - CATSmart (FDA 510(k) Clearance)

K180831 · Fresenius Kabi AG · Cardiovascular device

Dec 2018

Decision

255d

Days

Class 2

Risk

K180831 is an FDA 510(k) clearance for the CATSmart. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on December 10, 2018, 255 days after receiving the submission on March 30, 2018.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K180831 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 2018
Decision Date	December 10, 2018
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF