FDA 510(k) Applications Submitted by PREETI JAIN

FDA 510(k) Number Submission Date Device Name Applicant
K050109 01/18/2005 TRILLIUM BIOPUMP PLUS, MODEL BPX80T MEDTRONIC PERFUSION SYSTEMS
K070213 01/22/2007 PERFORMER CBP SYSTEM RAND S.R.L.
K080509 02/25/2008 CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE MEDTRONIC INC.
K030696 03/06/2003 RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) MEDTRONIC PERFUSION SYSTEMS
K080824 03/24/2008 BIO-CONSOLE 560 MEDTRONIC PERFUSION SYSTEMS
K021287 04/23/2002 TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT MEDTRONIC PERFUSION SYSTEMS
K221401 05/16/2022 Self-Cath and Self-Cath Plus Coloplast
K031700 06/02/2003 MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 MEDTRONIC PERFUSION SYSTEMS
K031827 06/13/2003 ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX MEDTRONIC PERFUSION SYSTEMS
K222059 07/13/2022 SpeediCath Flex Set Coloplast
K052555 09/16/2005 MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB RAND S.R.L.
K033264 10/09/2003 MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES MEDTRONIC PERFUSION SYSTEMS
K223821 12/21/2022 Self-Cath Closed System Coloplast
K034058 12/30/2003 SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 MEDTRONIC VASCULAR


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact