Medical Device Manufacturer · US , Maple Grove , MN

Vascular Solutions, LLC

11 submissions · 11 cleared · Since 2019
11
Total
11
Cleared
0
Denied

Vascular Solutions, LLC — FDA 510(k) Submissions

Vascular Solutions, LLC has submitted 11 FDA 510(k) premarket notifications since 2019, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Wire, Guide, Catheter, Hemostatic Wound Dressing With Thrombin Or Other Biologics, Catheter, Intravascular, Diagnostic, Catheters, Transluminal Coronary Angioplasty, Percutaneous . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Ringer 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 (58
K233729 · LOX Catheters, Transluminal... · Cardiovascular
May 2024 192d
Wattson temporary pacing guidewire (2250)
K230637 · DQX Wire, Guide, Catheter · Cardiovascular
May 2023 59d
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
K220647 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2022 164d
Langston dual lumen catheter
K221470 · DQO Catheter, Intravascular,... · Cardiovascular
Jun 2022 28d
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
K212167 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2022 212d
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
K212211 · DQY Catheter, Percutaneous · Cardiovascular
Feb 2022 209d
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
K210647 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2021 58d
Twin-Pass Dual Access Catheter
K193119 · DQY Catheter, Percutaneous · Cardiovascular
Jun 2020 230d
D-Stat Radial Topical Hemostat
K200720 · QSX Hemostatic Wound Dressing... · General & Plastic Surgery
Jun 2020 99d
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
K191560 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2019 57d
Venture 0.014 Catheter
K182570 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2019 176d
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