FDA 510(k) Applications Submitted by AMY MCKINNEY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200061 |
01/13/2020 |
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) |
Galil Medical Inc. |
| K120285 |
01/31/2012 |
K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER |
CURATIVE MEDICAL INC. |
| K090427 |
02/19/2009 |
URSA ANGIOGRAPHIC CATHETER |
CURATIVE MEDICAL TECHNOLOGY, INC. |
| K230551 |
02/28/2023 |
Visual-ICE Cryoablation System |
Boston Scientific Corporation |
| K130663 |
03/12/2013 |
BESTFIT2 NASAL MASK |
CURATIVE MEDICAL INC. |
| K130828 |
03/26/2013 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
| K131702 |
06/11/2013 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
| K111859 |
06/30/2011 |
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL INC. |
| K203032 |
10/05/2020 |
IcePearl 2.1 CX 90░ Needle, IcePearl 2.1 CX L 90░ Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90░ Needle, IceFORCE 2.1 CX L 90░ Needle, IceFORCE 2.1 CX Needle |
Galil Medical Inc. |
| K123818 |
12/12/2012 |
URSA ANGIOGRAPHIC CATHETER |
CURATIVE MEDICAL TECHNOLOGY, INC. |
| K143564 |
12/16/2014 |
Visual-ICE Cryoablation System, Software Revision 1.3.1 |
GALIL MEDICAL INC. |
| K123865 |
12/17/2012 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
| K063733 |
12/18/2006 |
RESOLVE BILIARY DRAINAGE CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
| K123897 |
12/18/2012 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
| K113860 |
12/30/2011 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
|
|
