Cleared Traditional

CAPIOX BUBBLE TRAP WITH X-COATING

K090698 · Terumo Cardiovascular Systems · Cardiovascular

Jun 2009

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K090698 is an FDA 510(k) clearance for the CAPIOX BUBBLE TRAP WITH X-COATING, a Detector, Bubble, Cardiopulmonary Bypass (Class II — Special Controls, product code KRL), submitted by Terumo Cardiovascular Systems (Elkton, US). The FDA issued a Cleared decision on June 8, 2009, 83 days after receiving the submission on March 17, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number	K090698 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2009
Decision Date	June 08, 2009
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF