FDA 510(k) Applications Submitted by Rick Gaykowski
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170041 |
01/05/2017 |
XableCath Support Catheter |
XABLECATH, INC. |
| K980578 |
02/17/1998 |
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) |
INNERDYNE, INC. |
| K990493 |
02/17/1999 |
INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE |
INNERDYNE, INC. |
| K970754 |
03/03/1997 |
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP |
INNERDYNE, INC. |
| K020733 |
03/06/2002 |
PVS 1500 SDS |
PRECISION VASCULAR SYSTEMS, INC. |
| K050630 |
03/11/2005 |
PIVOT STEERABLE MICROCATHETER |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
| K990854 |
03/15/1999 |
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE |
INNERDYNE, INC. |
| K971230 |
04/02/1997 |
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT |
INNERDYNE, INC. |
| K961430 |
04/15/1996 |
INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP |
INNERDYNE, INC. |
| K180986 |
04/16/2018 |
XableCath Support Catheter Product Family |
XableCath, Inc. |
| K050964 |
04/18/2005 |
PV 1900 SYNCHRO 0.016 GUIDEWIRE |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
| K091324 |
05/05/2009 |
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET |
C.R. BARD, INC. |
| K961940 |
05/20/1996 |
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP |
INNERDYNE, INC. |
| K982417 |
07/13/1998 |
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP |
INNERDYNE, INC. |
| K032146 |
07/14/2003 |
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES |
PRECISION VASCULAR SYSTEMS, INC. |
| K972684 |
07/17/1997 |
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM |
INNERDYNE, INC. |
| K992668 |
08/09/1999 |
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) |
INNERDYNE, INC. |
| K032494 |
08/13/2003 |
PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER |
PRECISION VASCULAR SYSTEMS, INC. |
| K023700 |
11/04/2002 |
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE |
PRECISION VASCULAR SYSTEMS, INC. |
| K053268 |
11/23/2005 |
PVS 2000 SYNCHRO2 GUIDEWIRE |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
| K033726 |
11/28/2003 |
PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER |
PRECISION VASCULAR |
| K183357 |
12/04/2018 |
XableCath Crossing Catheter |
XableCath, Inc. |
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