CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

Apparatus, Autotransfusion

SORIN BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Code 150 Blood Component Collection Set And With Direct Draw Line.

Pre-market Notification Details

• Device ID: K963758
• 510k Number: K963758
• Device Name: CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
• Classification: Apparatus, Autotransfusion
• Applicant: SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751
• Contact: Susan J Reimers
• Correspondent: Susan J Reimers; SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751
• Product Code: CAC
• CFR Regulation Number: 868.5830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-18
• Decision Date: 1998-02-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18033178105689	K963758	000
18033178105610	K963758	000
38033178105461	K963758	000