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 |
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