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Vascular Solutions, LLC

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest FDA decision2024-05-31
TypeNumberDevice NameCodeDateActions
510(k) K233729 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 (58LOX2024-05-31 View
510(k) K230637 Wattson temporary pacing guidewire (2250)DQX2023-05-05 View
510(k) K220647 GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)DQY2022-08-18 View
510(k) K221470 Langston dual lumen catheterDQO2022-06-17 View
510(k) K212167 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireDQX2022-02-09 View
510(k) K212211 Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheterDQY2022-02-09 View
510(k) K210647 SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterDQY2021-04-30 View
510(k) K193119 Twin-Pass Dual Access CatheterDQY2020-06-29 View
510(k) K200720 D-Stat Radial Topical HemostatQSX2020-06-26 View
510(k) K191560 Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterDQY2019-08-09 View
510(k) K182570 Venture 0.014 CatheterDQY2019-03-13 View