Cleared Traditional

CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA

K901074 · Dlp, Inc. · Cardiovascular

Jul 1990

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K901074 is an FDA 510(k) clearance for the CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on July 6, 1990, 120 days after receiving the submission on March 8, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K901074 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 1990
Decision Date	July 06, 1990
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

Device Classification

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