Home / 510(k) Clearances / K162272

510(k) K162272

Fluent inflation device by Vascular Solutions, Inc. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2016
Date Received
August 12, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Vascular Solutions, Inc.

  • K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
  • K230637 — Wattson temporary pacing guidewire (2250) (May 5, 2023)
  • K220647 — GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (August 18, 2022)
  • K221470 — Langston dual lumen catheter (June 17, 2022)
  • K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold (February 9, 2022)
  • K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior g (February 9, 2022)
  • K210647 — SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcathet (April 30, 2021)
  • K193119 — Twin-Pass Dual Access Catheter (June 29, 2020)
  • K200720 — D-Stat Radial Topical Hemostat (June 26, 2020)
  • K192454 — Wattson Temporary Pacing Guidewire (January 15, 2020)

Other clearances for product code MAV

  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)
  • K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE (December 19, 2012)