FDA 510(k) Applications Submitted by MICHELLE NIVALA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150190 |
01/27/2015 |
IntraTemp Solution Warmer |
Ecolab Inc. |
| K080994 |
04/07/2008 |
AMPLATZER TORQVUE EXCHANGE SYSTEM |
AGA MEDICAL CORP. |
| K061416 |
05/22/2006 |
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 |
MEDTRONIC VASCULAR |
| K061480 |
05/30/2006 |
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM |
MEDTRONIC IRELAND |
| K071641 |
06/15/2007 |
REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) |
MEDTRONIC INC. |
| K071655 |
06/18/2007 |
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 |
MEDTRONIC INC. |
| K052459 |
09/07/2005 |
6248VAL ADJUSTABLE VALVE |
MEDTRONIC VASCULAR |
| K063210 |
10/23/2006 |
ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 |
MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT |
| K053431 |
12/09/2005 |
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM |
MEDTRONIC IRELAND |
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