MODIFICATION TO: STOCKERT S5 SYSTEM

Console, Heart-lung Machine, Cardiopulmonary Bypass

SORIN GROUP DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Modification To: Stockert S5 System.

Pre-market Notification Details

• Device ID: K071318
• 510k Number: K071318
• Device Name: MODIFICATION TO: STOCKERT S5 SYSTEM
• Classification: Console, Heart-lung Machine, Cardiopulmonary Bypass
• Applicant: SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760
• Contact: Rosina Robinson
• Correspondent: Rosina Robinson; SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: DTQ
• CFR Regulation Number: 870.4220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-10
• Decision Date: 2007-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04033817900573	K071318	000
04033817900399	K071318	000
04033817900382	K071318	000
04033817900375	K071318	000
04033817900368	K071318	000
04033817900351	K071318	000
04033817900344	K071318	000
04033817900337	K071318	000
04033817900320	K071318	000
04033817900313	K071318	000
04033817900306	K071318	000
04033817900290	K071318	000
04033817900405	K071318	000
04033817900412	K071318	000
04033817900566	K071318	000
04033817900559	K071318	000
04033817900535	K071318	000
04033817900498	K071318	000
04033817900481	K071318	000
04033817900474	K071318	000
04033817900467	K071318	000
04033817900450	K071318	000
04033817900443	K071318	000
04033817900436	K071318	000
04033817900429	K071318	000
04033817900283	K071318	000
04033817900276	K071318	000
04033817900139	K071318	000
04033817900122	K071318	000
04033817900115	K071318	000
04033817900108	K071318	000
04033817900092	K071318	000
04033817900085	K071318	000
04033817900078	K071318	000
04033817900061	K071318	000
04033817900054	K071318	000
04033817900047	K071318	000
04033817900030	K071318	000
04033817900146	K071318	000
04033817900153	K071318	000
04033817900269	K071318	000
04033817900252	K071318	000
04033817900245	K071318	000
04033817900238	K071318	000
04033817900221	K071318	000
04033817900214	K071318	000
04033817900207	K071318	000
04033817900191	K071318	000
04033817900184	K071318	000
04033817900177	K071318	000
04033817900160	K071318	000
04033817900023	K071318	000
34033817900635	K071318	000
04033817901341	K071318	000
04033817901334	K071318	000
04033817901327	K071318	000
04033817901280	K071318	000
04033817901273	K071318	000
04033817901259	K071318	000
04033817901242	K071318	000
04033817901235	K071318	000
04033817901211	K071318	000
04033817901082	K071318	000
04033817901068	K071318	000
04033817901358	K071318	000
04033817901365	K071318	000
34033817900628	K071318	000
04033817903147	K071318	000
04033817903130	K071318	000
04033817901976	K071318	000
04033817901648	K071318	000
04033817901563	K071318	000
04033817901419	K071318	000
04033817901402	K071318	000
04033817901396	K071318	000
04033817901389	K071318	000
04033817901372	K071318	000
04033817901051	K071318	000
04033817901044	K071318	000
04033817900795	K071318	000
04033817900788	K071318	000
04033817900771	K071318	000
04033817900764	K071318	000
04033817900757	K071318	000
04033817900740	K071318	000
04033817900665	K071318	000
04033817900658	K071318	000
04033817900610	K071318	000
04033817900603	K071318	000
04033817900597	K071318	000
04033817900818	K071318	000
04033817900825	K071318	000
04033817901037	K071318	000
04033817900993	K071318	000
04033817900917	K071318	000
04033817900900	K071318	000
04033817900894	K071318	000
04033817900887	K071318	000
04033817900870	K071318	000
04033817900863	K071318	000
04033817900856	K071318	000
04033817900849	K071318	000
04033817900832	K071318	000
04033817900580	K071318	000