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510(k) K092563

GATOR CLIPSEAL PLUG by Vascular Solutions, Inc. — Product Code DTL

K092563 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "GATOR CLIPSEAL PLUG". The FDA issued a decision of Substantially Equivalent on November 4, 2009. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2009
Date Received
August 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
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)
  • K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior g (February 9, 2022)
  • K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold (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 DTL

  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • K143429 — Passage Hemostasis Valve (December 22, 2014)
  • K140475 — ROTATING ADAPTERS (April 16, 2014)
  • K131124 — COLIGN (August 28, 2013)
  • K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE L (December 13, 2012)
  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (October 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (September 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (April 3, 2012)
  • K113148 — E-PASS (February 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (January 25, 2012)

FDA data resources