FDA 510(k) Applications Submitted by VASCULAR SOLUTIONS, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K161336 |
05/13/2016 |
VSI StraitSet micro-introducer kit |
VASCULAR SOLUTIONS, INC. |
K143038 |
10/22/2014 |
Gel-Block 10X embolization pledgets |
VASCULAR SOLUTIONS, INC. |
K072618 |
09/17/2007 |
TWIN-PASS OTW CATHETER, MODEL 5201 |
VASCULAR SOLUTIONS, INC. |
K073585 |
12/20/2007 |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 |
VASCULAR SOLUTIONS, INC. |
K063871 |
12/29/2006 |
D-STAT HANDLE, MODEL 8500-053 |
VASCULAR SOLUTIONS, INC. |
K181647 |
06/22/2018 |
Bandit guidewire |
Vascular Solutions, Inc. |
K180088 |
01/12/2018 |
TrapLiner catheter |
Vascular Solutions, Inc. |
K151234 |
05/08/2015 |
R350 guidewire |
VASCULAR SOLUTIONS, INC. |
K171335 |
05/08/2017 |
Venture 038 catheter |
Vascular Solutions, Inc. |
K161702 |
06/20/2016 |
Endura guidewire |
Vascular Solutions, Inc. |
K161901 |
07/11/2016 |
TrapLiner catheter |
Vascular Solutions, Inc. |
K172090 |
07/11/2017 |
GuideLiner V3 Catheter |
Vascular Solutions, Inc. |
K162272 |
08/12/2016 |
Fluent inflation device |
VASCULAR SOLUTIONS, INC. |
K152387 |
08/24/2015 |
Fluent Inflation Device |
VASCULAR SOLUTIONS, INC. |
K173532 |
11/15/2017 |
Raider Guidewire |
Vascular Solutions, Inc. |
K163444 |
12/08/2016 |
Spectre guidewire |
Vascular Solutions, Inc. |
K090977 |
04/06/2009 |
PIGGYBACK WIRE CONVERTER |
VASCULAR SOLUTIONS, INC. |
K081846 |
06/30/2008 |
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 |
VASCULAR SOLUTIONS, INC. |
K082337 |
08/14/2008 |
MINNIE SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
K083784 |
12/19/2008 |
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, |
VASCULAR SOLUTIONS, INC. |
K030654 |
03/03/2003 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
K030836 |
03/17/2003 |
D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE |
VASCULAR SOLUTIONS, INC. |
K032204 |
07/18/2003 |
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
K032805 |
09/09/2003 |
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
K080022 |
01/03/2008 |
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP |
VASCULAR SOLUTIONS, INC. |
K072332 |
08/20/2007 |
VARI-LASE WIRE FIBER |
VASCULAR SOLUTIONS, INC. |
K012293 |
07/20/2001 |
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
K033237 |
10/06/2003 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE |
VASCULAR SOLUTIONS, INC. |
K070216 |
01/23/2007 |
VARI-LASE BRIGHT TIP FIBER |
VASCULAR SOLUTIONS, INC. |
K040730 |
03/22/2004 |
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP |
VASCULAR SOLUTIONS, INC. |
K042937 |
10/25/2004 |
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K070403 |
02/12/2007 |
PRONTO .035 EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K072810 |
10/01/2007 |
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 |
VASCULAR SOLUTIONS, INC. |
K120707 |
03/08/2012 |
SWITCH-IT CATHETER |
VASCULAR SOLUTIONS, INC. |
K142065 |
07/30/2014 |
TURNPIKE CATHETER |
VASCULAR SOLUTIONS, INC. |
K132789 |
09/06/2013 |
FLIP INTRODUCER ACCESS KIT |
VASCULAR SOLUTIONS, INC. |
K133237 |
10/21/2013 |
GEL-BEAD EMBOLIZATION SPHERES |
VASCULAR SOLUTIONS, INC. |
K032763 |
09/05/2003 |
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K040510 |
02/27/2004 |
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD |
VASCULAR SOLUTIONS, INC. |
K040118 |
01/20/2004 |
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC |
VASCULAR SOLUTIONS, INC. |
K033709 |
11/26/2003 |
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE |
VASCULAR SOLUTIONS, INC. |
K182232 |
08/17/2018 |
Octane Mechanical Thrombectomy System |
Vascular Solutions, Inc. |
K170544 |
02/24/2017 |
Langston dual lumen catheter |
Vascular Solutions, Inc. |
K180913 |
04/09/2018 |
VSI Micro-Introducer Kit |
Vascular Solutions, Inc. |
K163307 |
11/23/2016 |
Expro Elite Snare, Sympro Elite Snare |
Vascular Solutions, Inc. |
K080104 |
01/14/2008 |
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 |
VASCULAR SOLUTIONS, INC. |
K070938 |
04/04/2007 |
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
K072117 |
08/01/2007 |
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH |
VASCULAR SOLUTIONS, INC. |
K073264 |
11/20/2007 |
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 |
VASCULAR SOLUTIONS, INC. |
K063860 |
12/28/2006 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
K113140 |
10/25/2011 |
VARI-LASE WIREFIBER LASER FIBER |
VASCULAR SOLUTIONS, INC. |
K100093 |
01/13/2010 |
VSI TORQUE DEVICE |
VASCULAR SOLUTIONS, INC. |
K111334 |
05/12/2011 |
BENELLI ACCESS DEVICE |
VASCULAR SOLUTIONS, INC. |
K101604 |
06/08/2010 |
VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V |
VASCULAR SOLUTIONS, INC. |
K101625 |
06/09/2010 |
COHEN CROSSOVER CATHETER |
VASCULAR SOLUTIONS, INC. |
K113266 |
11/04/2011 |
GEL-BLOCK EMBOLIZATION PLEDGETS |
VASCULAR SOLUTIONS, INC. |
K093502 |
11/12/2009 |
VARI-LASE ENDOVENOUS LASER CONSOLE |
VASCULAR SOLUTIONS, INC. |
K070372 |
02/08/2007 |
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 |
VASCULAR SOLUTIONS, INC. |
K060327 |
02/09/2006 |
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
K061219 |
05/01/2006 |
D-STAT DRY HEMOSTATIC BANDAGE |
VASCULAR SOLUTIONS, INC. |
K061565 |
06/05/2006 |
LANGSTON DUAL LUMEN CATHETER |
VASCULAR SOLUTIONS, INC. |
K071727 |
06/25/2007 |
QXT EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K062877 |
09/26/2006 |
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 |
VASCULAR SOLUTIONS, INC. |
K063371 |
11/08/2006 |
PRONTO V3 EXTRACTION CATHETER, MODEL 5003 |
VASCULAR SOLUTIONS, INC. |
K073200 |
11/13/2007 |
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 |
VASCULAR SOLUTIONS, INC. |
K050021 |
01/05/2005 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
K050133 |
01/21/2005 |
D-STAT RADIAL HEMOSTATIC BAND |
VASCULAR SOLUTIONS, INC. |
K050146 |
01/24/2005 |
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY |
VASCULAR SOLUTIONS, INC. |
K050511 |
03/01/2005 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
K051287 |
05/18/2005 |
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
K053054 |
10/31/2005 |
THROMBIX 3X3 HEMOSTATIC PAD |
VASCULAR SOLUTIONS, INC. |
K053644 |
12/30/2005 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
K171946 |
06/29/2017 |
Gel-Bead |
Vascular Solutions, Inc. |
K102212 |
08/06/2010 |
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER |
VASCULAR SOLUTIONS, INC. |
K092612 |
08/26/2009 |
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 |
VASCULAR SOLUTIONS, INC. |
K162467 |
09/02/2016 |
Twin-Pass Torque |
VASCULAR SOLUTIONS, INC. |
K083190 |
10/29/2008 |
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 |
VASCULAR SOLUTIONS, INC. |
K173891 |
12/21/2017 |
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume |
Vascular Solutions, Inc. |
K091345 |
05/06/2009 |
GOPHER GOLD CATHETER, MODEL 5620 |
VASCULAR SOLUTIONS, INC. |
K091551 |
05/27/2009 |
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER |
VASCULAR SOLUTIONS, INC. |
K091750 |
06/16/2009 |
GUIDELINER CATHETER, MODELS 5571, 5572, 5573 |
VASCULAR SOLUTIONS, INC. |
K092563 |
08/20/2009 |
GATOR CLIPSEAL PLUG |
VASCULAR SOLUTIONS, INC. |
K101659 |
06/11/2010 |
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 |
VASCULAR SOLUTIONS, INC. |
K112082 |
07/21/2011 |
GUIDELINER V2 CATHETER |
VASCULAR SOLUTIONS, INC. |
K112100 |
07/22/2011 |
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER |
VASCULAR SOLUTIONS, INC. |
K112571 |
09/06/2011 |
XL EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K103405 |
11/19/2010 |
PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH |
VASCULAR SOLUTIONS, INC. |
K112631 |
09/09/2011 |
VSI GUIDEWIRE |
VASCULAR SOLUTIONS, INC. |
K133501 |
11/14/2013 |
LEADLINER CS LEAD DELIVERY SYSTEM |
VASCULAR SOLUTIONS, INC. |
K062627 |
09/05/2006 |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 |
VASCULAR SOLUTIONS, INC. |
K062822 |
09/20/2006 |
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 |
VASCULAR SOLUTIONS, INC. |
K063851 |
12/28/2006 |
AUTO-FILL SYRINGE KIT, MODEL 7600 |
VASCULAR SOLUTIONS, INC. |
K050168 |
01/26/2005 |
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER |
VASCULAR SOLUTIONS, INC. |
K051193 |
05/10/2005 |
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K051395 |
05/27/2005 |
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER |
VASCULAR SOLUTIONS, INC. |
K041909 |
07/15/2004 |
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) |
VASCULAR SOLUTIONS, INC. |
K052232 |
08/17/2005 |
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
K052257 |
08/18/2005 |
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER |
VASCULAR SOLUTIONS, INC. |
K052258 |
08/19/2005 |
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
K043019 |
11/03/2004 |
VASCULAR SOLUTIONS SCLERO-KIT |
VASCULAR SOLUTIONS, INC. |
K033721 |
11/26/2003 |
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT |
VASCULAR SOLUTIONS, INC. |
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