VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR

Reservoir, Blood, Cardiopulmonary Bypass

SORIN BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir.

Pre-market Notification Details

• Device ID: K941215
• 510k Number: K941215
• Device Name: VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
• Classification: Reservoir, Blood, Cardiopulmonary Bypass
• Applicant: SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751
• Contact: Ronald S Warren
• Correspondent: Ronald S Warren; SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751
• Product Code: DTN
• CFR Regulation Number: 870.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-10
• Decision Date: 1995-05-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
38033178250277	K941215	000
38033178250253	K941215	000