FDA.reportPublic FDA data

VASCULAR SOLUTIONS LLC

Matched from indexed company URL: Vascular Solutions, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21348123002827704VASCULAR SOLUTIONS LLC1Y2026-01-016464 Sycamore Court North Maple Grove MN US 55369

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M206780500SmartNeedle® vascular access system - Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.888-240-6001customerservice@vasc.com
M206780600SmartNeedle® vascular access system - Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.888-240-6001customerservice@vasc.com
M20679600VSI StraitSet™ micro-introducer kit - 7960888-240-6001customerservice@vasc.com
M20679610VSI StraitSet™ micro-introducer kit - 7961888-240-6001customerservice@vasc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
170381098306789P990037VASCULAR SOLUTIONS DUETT SEALING DEVICEMGB2000-06-22
170381861755665P180025MANTA Vascular Closure DeviceMGB2019-02-01
170381571604120K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CARITX1998-01-23
170381040797479K963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICEITX1997-04-24
170381718181790K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATIONITX1994-06-10
170381307942233K940444GENERAL SURGERY TRAYLRP1994-03-07
170381268193766K913941PSG(TM) 20 GUAGE DOPPLER NEEDLEITX1992-02-27
170381276469818K905639TORQUE HANDLE DEVICE FOR GUIDEWIREDQX1991-02-20
170381101741766K903625DOPPLER NEEDLE AND FLOW MONITORDPW1990-11-07
170381228975873K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58LOX2024-05-31
170381910197786K230637Wattson temporary pacing guidewire (2250)DQX2023-05-05
170381163879727K221470Langston dual lumen catheterDQO2022-06-17
170381036001357K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)DQY2022-08-18
170382037237065K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterDQY2021-04-30
170381519827155K200720D-Stat Radial Topical HemostatQSX2020-06-26
170381317270827K193119Twin-Pass Dual Access CatheterDQY2020-06-29
170381032725044K192454Wattson Temporary Pacing GuidewireDQX2020-01-15
170382050400122K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterDQY2019-08-09
170381069302575K182570Venture 0.014 CatheterDQY2019-03-13
170381118705557K181647Bandit guidewireDQX2018-07-20
170381335068271K180913VSI Micro-Introducer KitDYB2018-05-09
170381800422601K180128Warrior 14 guidewireDQX2018-02-16
170382037255363K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volumeKRD2018-01-19
170381630068735K173532Raider GuidewireDQX2017-12-15
170381439518773K173266Octane aspiration systemQEZ2017-12-01
170381825487364K172090GuideLiner V3 CatheterDQY2017-10-20
170381904963422K171946Gel-BeadKRD2017-10-25
170381628835633K171335Venture 038 catheterDQY2017-06-07
170381731775427K163444Spectre guidewireDQX2017-01-06
170381296000337K163307Expro Elite Snare, Sympro Elite SnareMMX2017-03-08
170381013951877K162467Twin-Pass TorqueDQY2017-02-01
170381952161895K162272Fluent inflation deviceMAV2016-10-20
170381786777624K161901TrapLiner catheterDQY2017-02-03
170381401043405K161336VSI StraitSet micro-introducer kitDRE2016-08-11
170381546485428K153682Chocolate XD PTCA Balloon CatheterLOX2016-06-23
170381129741154K151981Turnpike catheterDQY2015-08-13
170381999654447K151234R350 guidewireDQX2015-11-18
170381632486990K143038Gel-Block 10X embolization pledgetsKRD2014-11-20
170381062856834K142377The OnControl Bone Marrow Biopsy System by VidacareKNW2014-12-17
170381150433939K142065TURNPIKE CATHETERDQY2014-11-25
170381107164291K133237GEL-BEAD EMBOLIZATION SPHERESKRD2014-04-25
170381598600424K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEDTL2012-09-07
170381464683429K121681GLIDER PTCA BALLOON CATHETERLOX2012-06-26
170381539011218K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREKNW2012-03-08
170381307539256K112631VSI GUIDEWIREDQX2011-10-27
170381041723180K112082GUIDELINER V2 CATHETERDQY2011-12-01
170381004362257K111837RADIAL ARTERY COMPRESSION TOURNIQUETDXC2011-09-27
170381120048464K103405PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATHQEZ2010-12-22
170381054568994K102212D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVERQSX2011-04-08
170381174646636K101659SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301DQY2010-12-16
170381950367599K101604VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274VDYB2011-01-24
170381058061024K101113GUARDIAN II NC HEMOSTASIS VALVEDTL2010-05-21
170381972315309K100093VSI TORQUE DEVICEDQX2010-04-30
170382013451488K093613VASCUVIEW TAP ULTRASOUND SYSTEMIYN2009-12-23
170381439540934K093502VARI-LASE ENDOVENOUS LASER CONSOLEGEX2010-01-07
170381140165418K092711GUARDIAN II HEMOSTASIS VALVEDTL2009-10-01
170381503950349K092612D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505QSX2009-09-11
170381441972560K091551VARI-LASE PLATINUM BRIGHT TIP LASER FIBERGEX2009-06-19
170381446697244K090977PIGGYBACK WIRE CONVERTERDQY2009-06-18
170381463667047K083784PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,QEZ2009-03-30
170381451944080K082337MINNIE SUPPORT CATHETERDQY2009-01-15
170381410350767K081846GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951DQO2009-01-28
170381504241702K073264D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005QSX2007-12-07
170381495556982K072810PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010QEZ2007-12-19
170381158078798K072117THROMBIX PATCH THROMBIN HEMOSTASIS PATCHQSX2007-10-05
170381084078798K072045ONCONTROL BONE MARROW BIOPSY SYSTEMKNW2007-10-22
170381811020322K071457MODIFICATION TO RADIUS SNAREMMX2007-09-25
170381143081788K070502RADIUS SNAREDQY2007-10-04
170381475373195K070403PRONTO .035 EXTRACTION CATHETERQEZ2007-06-13
170381406012660K070216VARI-LASE BRIGHT TIP FIBERGEX2007-03-16
170381990579659K063860THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTATQSX2007-02-13
170381506238262K063851AUTO-FILL SYRINGE KIT, MODEL 7600FMF2007-01-26
170381086423592K063371PRONTO V3 EXTRACTION CATHETER, MODEL 5003QEZ2006-12-14
170381742713311K061843VENTURE WIRE CONTROL CATHETER, MODEL WCCDQY2006-08-01
170381879457481K061565LANGSTON DUAL LUMEN CATHETERDQO2006-08-02
170381440607197K061219D-STAT DRY HEMOSTATIC BANDAGEQSX2006-10-06
170381632660611K053054THROMBIX 3X3 HEMOSTATIC PADQSX2005-11-23
170381144582146K052257VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETERDQY2005-11-23
170381982319754K052232VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETERQEZ2005-09-28
170381024838119K051395LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETERDQO2005-06-24
170381058481577K051287VARI-LASE ENDOVENOUS LASER PROCEDURE KITGEX2005-07-29
170381227193300K050168LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETERDQO2005-05-18
170381333788473K050146VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORYDXC2005-05-27
170381150185398K050133D-STAT RADIAL HEMOSTATIC BANDQSX2005-02-18
170381675870131K050021VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KITGEX2005-03-18
170381167730181K043525CATHETER INTRODUCERDYB2005-02-09
170381800961219K042910VENTURE WIRE CONTROL CATHETER, MODEL WCCDQY2004-11-22
170381893067711K041909VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)DQO2004-09-23
170381618001337K040922VENTURE WIRE CONTROL CATHETERDQY2004-08-18
170381449448888K040730VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMPDXC2004-06-18
170381792261413K040510VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PADQSX2004-03-17
170381685359272K040118VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATICQSX2004-02-12
170381059168211K033721VASCULAR SOLUTIONS AUTO-FILL SYRINGE KITFMF2004-02-13
170381545189316K033709VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGEQSX2003-12-18
170381218092109K033237VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLEGEX2003-11-20
170381357612398K032805MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KITGEX2003-10-01
170381465111497K032204MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KITGEX2003-08-20
170381600609142K031652VASCUPUNCTURE PICC GUIDEWIREDQX2003-09-30
170381685959479K030836D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGEQSX2003-09-17
170381992567187K030654VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KITGEX2003-06-18
170381987813259K022201RADIUS MICRO SNAREMMX2003-02-03
170381044586284K021441RADIUS SNAREMMX2002-06-14
170381084137911K012293VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTATQSX2002-01-18
170381550815300K000011MODIFIED HYDROPHILIC COATED GUIDEWIREDQX2000-03-01
170381981829914
170381013265722
170381024970163
170381259182428
170381259894902
170381478179412
170381669476897
170381758860668
170381767064916
170381806565253
170381921997199
170381997645253

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY202022-08-18
QSX142020-06-26
DQX132023-05-05
GEX92010-01-07
QEZ72017-12-01
DQO62022-06-17
KRD42018-01-19
MMX42017-03-08
ITX41998-01-23
LOX32024-05-31
DYB32018-05-09
KNW32014-12-17
DTL32012-09-07
DXC32011-09-27
MGB22019-02-01
FMF22007-01-26
MAV12016-10-20
DRE12016-08-11
IYN12009-12-23
LRP11994-03-07
DPW11990-11-07

PMA#

Duett Sealing (D-Stat Flowable)

2022-11-04

Vascular Solutions, Inc.6464 Sycamore Court Northminneapolis, MN 55369 PMA NumberP990037 Supplement NumberS036 Date Received08/08/2022 Decision Date11/04/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement...

PMN#

Gel-Bead

2017-10-25

Vascular Solutions, Inc.

114 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next