XTRA

Apparatus, Autotransfusion

SORIN GROUP ITALIA S.R.L

The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Xtra.

Pre-market Notification Details

• Device ID: K112245
• 510k Number: K112245
• Device Name: XTRA
• Classification: Apparatus, Autotransfusion
• Applicant: SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET Waltham, MA 02451
• Contact: Barry Sall
• Correspondent: Barry Sall; SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET Waltham, MA 02451
• Product Code: CAC
• CFR Regulation Number: 868.5830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-04
• Decision Date: 2011-09-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04033817752219	K112245	000