Company ยท US
Vascular Solutions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2024. Name variants (Inc, Corp, punctuation) are merged.
115510(k) clearances (0 in 12 months)
29recalls (0 in 12 months)
28recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQY | Catheter, Percutaneous | 33 |
| DQO | Catheter, Intravascular, Diagnostic | 22 |
| QSX | Hemostatic Wound Dressing With Thrombin Or Other Biologics | 18 |
| GEX | Powered Laser Surgical Instrument | 15 |
| QEZ | Aspiration Thrombectomy Catheter | 13 |
| DQX | Wire, Guide, Catheter | 11 |
| KRD | Device, Vascular, For Promoting Embolization | 5 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 |
| DXC | Clamp, Vascular | 3 |
| DXE | Catheter, Embolectomy | 3 |
| DYB | Introducer, Catheter | 3 |
| FRO | Dressing, Wound, Drug | 3 |
| MAV | Syringe, Balloon Inflation | 3 |
| FMF | Syringe, Piston | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| KGZ | Accessories, Catheter | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 |
| MMX | Device, Percutaneous Retrieval | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 2024 | K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer per Vascular Solutions, LLC | LOX |
| May 5, 2023 | K230637 | Wattson temporary pacing guidewire (2250) Vascular Solutions, LLC | DQX |
| Aug 18, 2022 | K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) Vascular Solutions, LLC | DQY |
| Jun 17, 2022 | K221470 | Langston dual lumen catheter Vascular Solutions, LLC | DQO |
| Feb 9, 2022 | K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapL Vascular Solutions, LLC | DQY |
| Feb 9, 2022 | K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire Vascular Solutions, LLC | DQX |
| Apr 30, 2021 | K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter Vascular Solutions, LLC | DQY |
| Jun 29, 2020 | K193119 | Twin-Pass Dual Access Catheter Vascular Solutions, LLC | DQY |
| Jun 26, 2020 | K200720 | D-Stat Radial Topical Hemostat Vascular Solutions, LLC | QSX |
| Jan 15, 2020 | K192454 | Wattson Temporary Pacing Guidewire Vascular Solutions | DQX |
| Aug 9, 2019 | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter Vascular Solutions, LLC | DQY |
| Mar 13, 2019 | K182570 | Venture 0.014 Catheter Vascular Solutions, LLC | DQY |
| Sep 11, 2018 | K182232 | Octane Mechanical Thrombectomy System Vascular Solutions, Inc. | QEZ |
| Jul 20, 2018 | K181647 | Bandit guidewire Vascular Solutions, Inc. | DQX |
| May 9, 2018 | K180913 | VSI Micro-Introducer Kit Vascular Solutions, Inc. | DYB |
| Apr 4, 2018 | K180088 | TrapLiner catheter Vascular Solutions, Inc. | DQY |
| Feb 16, 2018 | K180128 | Warrior 14 guidewire Vascular Solutions, Inc. | DQX |
| Jan 19, 2018 | K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume Vascular Solutions, Inc. | KRD |
| Dec 15, 2017 | K173532 | Raider Guidewire Vascular Solutions, Inc. | DQX |
| Dec 1, 2017 | K173266 | Octane aspiration system Vascular Solutions, Inc. | QEZ |
| Nov 17, 2017 | K170544 | Langston dual lumen catheter Vascular Solutions, Inc. | DQO |
| Oct 25, 2017 | K171946 | Gel-Bead Vascular Solutions, Inc. | KRD |
| Oct 20, 2017 | K172090 | GuideLiner V3 Catheter Vascular Solutions, Inc. | DQY |
| Jun 7, 2017 | K171335 | Venture 038 catheter Vascular Solutions, Inc. | DQY |
| Mar 8, 2017 | K163307 | Expro Elite Snare, Sympro Elite Snare Vascular Solutions, Inc. | MMX |
| Feb 3, 2017 | K161901 | TrapLiner catheter Vascular Solutions, Inc. | DQY |
| Feb 1, 2017 | K162467 | Twin-Pass Torque Vascular Solutions, Inc. | DQY |
| Jan 6, 2017 | K163444 | Spectre guidewire Vascular Solutions, Inc. | DQX |
| Dec 6, 2016 | K161702 | Endura guidewire Vascular Solutions, Inc. | DQX |
| Oct 20, 2016 | K162272 | Fluent inflation device Vascular Solutions, Inc. | MAV |
| Aug 11, 2016 | K161336 | VSI StraitSet micro-introducer kit Vascular Solutions, Inc. | DRE |
| Dec 18, 2015 | K152387 | Fluent Inflation Device Vascular Solutions, Inc. | MAV |
| Nov 18, 2015 | K151234 | R350 guidewire Vascular Solutions, Inc. | DQX |
| Nov 25, 2014 | K142065 | TURNPIKE CATHETER Vascular Solutions, Inc. | DQY |
| Nov 20, 2014 | K143038 | Gel-Block 10X embolization pledgets Vascular Solutions, Inc. | KRD |
| Apr 25, 2014 | K133237 | GEL-BEAD EMBOLIZATION SPHERES Vascular Solutions, Inc. | KRD |
| Apr 17, 2014 | K132789 | FLIP INTRODUCER ACCESS KIT Vascular Solutions, Inc. | DYB |
| Feb 25, 2014 | K133501 | LEADLINER CS LEAD DELIVERY SYSTEM Vascular Solutions, Inc. | DQY |
| May 15, 2012 | K120707 | SWITCH-IT CATHETER Vascular Solutions, Inc. | DQY |
| May 14, 2012 | K113266 | GEL-BLOCK EMBOLIZATION PLEDGETS Vascular Solutions, Inc. | KRD |
| Mar 20, 2012 | K112100 | M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER Vascular Solutions, Inc. | DQY |
| Dec 22, 2011 | K113140 | VARI-LASE WIREFIBER LASER FIBER Vascular Solutions, Inc. | GEX |
| Dec 1, 2011 | K112082 | GUIDELINER V2 CATHETER Vascular Solutions, Inc. | DQY |
| Oct 27, 2011 | K112631 | VSI GUIDEWIRE Vascular Solutions, Inc. | DQX |
| Oct 6, 2011 | K112571 | XL EXTRACTION CATHETER Vascular Solutions, Inc. | QEZ |
| Aug 1, 2011 | K111334 | BENELLI ACCESS DEVICE Vascular Solutions, Inc. | DQY |
| Apr 8, 2011 | K102212 | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER Vascular Solutions, Inc. | QSX |
| Jan 24, 2011 | K101604 | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V Vascular Solutions, Inc. | DYB |
| Dec 22, 2010 | K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH Vascular Solutions, Inc. | QEZ |
| Dec 16, 2010 | K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 Vascular Solutions, Inc. | DQY |
Newest 50 of 115.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | K061565 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | K051395 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | K051395 |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter Terminated |
DQO | K051395 |
| Apr 27, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies Terminated |
DQO | K051395 |
| May 4, 2018 | Vascular Solutions, Inc. Drainer(R) Centesis Catheters:
(a) REF 8810, 5F x 9cm
(b) REF 8811, 6F x 9cm
(c) REF 8812, 5F x 15cm
Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and sm Terminated |
KGZ | None listed |
| May 22, 2017 | Vascular Solutions, Inc. Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only.
The Venture catheter is indicated for directing, stee Terminated |
DQY | K040922 K042910 +1 |
| Apr 12, 2017 | Vascular Solutions, Inc. Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide.
DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and de Terminated |
MAV | K042449 |
| Jan 12, 2017 | Vascular Solutions, Inc. GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide.
Product Usage:
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the va Terminated |
DQO | K081846 |
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and Terminated |
DQO | K062877 |
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or Terminated |
DQY | K060327 |
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the c Terminated |
DQY | K052257 |
| Apr 7, 2016 | Vascular Solutions, Inc. Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50.
Product Usage: The Guardian hemostasis valves Terminated |
DTL | K122301 |
| Jul 3, 2014 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast m Terminated |
DQO | K051395 |
| Mar 20, 2013 | Vascular Solutions, Inc. Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass.
Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, F Terminated |
DTL | K092711 K101113 +1 |
| Feb 20, 2013 | Vascular Solutions, Inc. Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341.
Product Usage:
The SuperCross catheter Terminated |
DQY | K101659 |
| Sep 17, 2012 | Vascular Solutions, Inc. Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102.
Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated Terminated |
DTL | K092711 K101113 |
| May 24, 2012 | Vascular Solutions, Inc. Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
Intended to be used in conjunction wit Terminated |
DQY | K112082 |
| Aug 4, 2011 | Vascular Solutions, Inc. Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in t Terminated |
DXE | K103405 |
| Jul 11, 2011 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
Langston dual lumen catheters a Terminated |
DQO | K061565 |
| Mar 3, 2011 | Vascular Solutions, Inc. Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369
The VARI-LASE WireFiber is indicated for the treatment of varicose Terminated |
GEX | K072332 |
| Sep 28, 2010 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Terminated |
DQO | K051395 |
| Dec 17, 2009 | Vascular Solutions, Inc. Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed Terminated |
DXE | K051193 |
| Aug 21, 2009 | Vascular Solutions, Inc. Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
The TWIN-PASS Terminated |
DQY | K060327 |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic ban Terminated |
FRO | K033709 |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Terminated |
FRO | K030836 |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage Terminated |
FRO | K030836 |
| Jul 20, 2004 | Vascular Solutions, Inc. The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. Terminated |
DXE | K032763 |
| Nov 6, 2003 | Vascular Solutions, Inc Vari-Lase Endovenous Laser Procedural Kit, Model 7000 Terminated |
GEX | K030654 |