STATFLO

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

IMODEX, INC.

The following data is part of a premarket notification filed by Imodex, Inc. with the FDA for Statflo.

Pre-market Notification Details

• Device ID: K880180
• 510k Number: K880180
• Device Name: STATFLO
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: IMODEX, INC. 29777 TELEGRAPH SUITE 2500 Southfield, MI 48034
• Contact: Sheldon H Davis
• Correspondent: Sheldon H Davis; IMODEX, INC. 29777 TELEGRAPH SUITE 2500 Southfield, MI 48034
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-01-13
• Decision Date: 1988-03-22