FDA 510(k) Applications Submitted by BRIAN PARK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160583 |
03/01/2016 |
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
VOLCANO CORPORATION |
| K001081 |
04/04/2000 |
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 |
CARDIODYNAMICS INTERNATIONAL CORP. |
| K070951 |
04/04/2007 |
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS |
BOSTON SCIENTIFIC |
| K001100 |
04/05/2000 |
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH |
CARDIODYNAMICS INTERNATIONAL CORP. |
| K011439 |
05/10/2001 |
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
CARDIODYNAMICS INTERNATIONAL CORP. |
| K161887 |
07/11/2016 |
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip |
Volcano Corporation |
| K123482 |
11/13/2012 |
REFLOW ASPIRATION CATHETER |
VOLCANO CORPORATION |
| K153369 |
11/23/2015 |
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz |
VOLCANO CORPORATION |
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