Sorin Group Italia S.R.L. - FDA 510(k) Cleared Devices

Cleared Jun 11, 2015

EOS PMP, EOS PMP Integrated

K150489 · DTZ

Cardiovascular · 106d

Cleared Aug 29, 2014

MEMO 3D ReChord

K142221 · KRH

Cardiovascular · 17d

Cleared Jun 06, 2013

XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR

K131103 · DTN

Cardiovascular · 48d

Cleared Mar 20, 2013

INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR,...

K130433 · DTZ

Cardiovascular · 27d

Cleared Feb 12, 2013

INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE...

K130209 · DTZ

Cardiovascular · 14d

Cleared Oct 17, 2012

INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...

K122844 · DTZ

Cardiovascular · 30d

Cleared Aug 24, 2012

INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...

K122254 · DTZ

Cardiovascular · 28d

Cleared Aug 22, 2012

INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR

K121536 · DTZ

Cardiovascular · 90d

Cleared Jul 26, 2012

INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL...

K121909 · DTZ

Cardiovascular · 27d

Cleared Jul 23, 2012

INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL...

K121229 · DTZ

Cardiovascular · 90d

Cleared May 11, 2012

INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...

K120185 · DTZ

Cardiovascular · 109d

Cleared Apr 05, 2012

INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...

K113626 · DTZ

Cardiovascular · 119d

Cleared Oct 14, 2011

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

K112771 · DTN

Cardiovascular · 21d

Cleared Sep 06, 2011

XTRA

K112245 · CAC

Anesthesiology · 33d

Cleared Apr 07, 2011

XVAC

K110782 · CAC

Anesthesiology · 17d

Cleared Nov 23, 2010

PREASSEMBLED SURGICAL WASH SET

K103202 · CAC

Anesthesiology · 22d

Cleared Oct 05, 2010

XTRA AUTOTRANSFUSION SYSTEM

K101586 · CAC

Anesthesiology · 120d

Cleared Mar 24, 2010

XRES BLOOD COLLECTION RESERVOIR

K100507 · DTN

Cardiovascular · 30d

Cleared Jan 22, 2010

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS

K093986 · DTM

Cardiovascular · 29d

Cleared Dec 18, 2009

AF 840 PH.I.S.I.O. ARTERIAL FILTER

K093601 · DTM

Cardiovascular · 28d

Cleared Oct 19, 2009

APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

K092895 · DTZ

Cardiovascular · 28d

Cleared Aug 12, 2009

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

K092315 · DTN

Cardiovascular · 13d

Cleared Nov 19, 2008

SH14 HEMOCONCENTRATOR

K081313 · KDI

Gastroenterology & Urology · 194d

Cleared Oct 29, 2008

APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

K083021 · DTZ

Cardiovascular · 20d

Cleared Feb 29, 2008

SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL...

K073380 · DTZ

Cardiovascular · 88d