Cleared Special

K180448 - INSPIRE 6M Hollow Fiber Oxygenator (FDA 510(k) Clearance)

Also includes:

INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter INSPIRE 8M Hollow Fiber Oxygenator INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter

K180448 · Sorin Group Italia S.R.L. · Cardiovascular device

Mar 2018

Decision

30d

Days

Class 2

Risk

K180448 is an FDA 510(k) clearance for the INSPIRE 6M Hollow Fiber Oxygenator. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).

Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 15, 2018, 30 days after receiving the submission on February 13, 2018.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number	K180448 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 2018
Decision Date	March 15, 2018
Days to Decision	30 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF