XTRA

Apparatus, Autotransfusion

SORIN GROUP DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Xtra.

Pre-market Notification Details

• Device ID: K131553
• 510k Number: K131553
• Device Name: XTRA
• Classification: Apparatus, Autotransfusion
• Applicant: SORIN GROUP DEUTSCHLAND GMBH 195 WEST STREET Waltham, MA 02451
• Contact: Barry Sall, Rac, Fraps
• Correspondent: Barry Sall, Rac, Fraps; SORIN GROUP DEUTSCHLAND GMBH 195 WEST STREET Waltham, MA 02451
• Product Code: CAC
• CFR Regulation Number: 868.5830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-30
• Decision Date: 2014-03-21
• Summary: summary