D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W

Oxygenator, Cardiopulmonary Bypass

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 D 100 L001 Ph.i.s.i.o.: Newborn Hollow Fiber Membrane Oxygenator With Integrated Hardshell Cardiotomy/venous Reservoir W.

Pre-market Notification Details

• Device ID: K061031
• 510k Number: K061031
• Device Name: D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451
• Contact: Barry Sall
• Correspondent: Barry Sall; SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-14
• Decision Date: 2006-06-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
38033178109780	K061031	000
38033178109612	K061031	000
38033178109308	K061031	000
38033178100350	K061031	000