Cleared Traditional

MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD

K090869 · Medtronic Perfusion Systems · Cardiovascular

Aug 2009

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K090869 is an FDA 510(k) clearance for the MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on August 27, 2009, 149 days after receiving the submission on March 31, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K090869 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2009
Decision Date	August 27, 2009
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210