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510(k) K180023

WIRION by Gardia Medical , Ltd. — Product Code NTE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2018
Date Received
January 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Carotid Catheter For Embolic Capture
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i

Other clearances by Gardia Medical , Ltd.

  • K143570 — WIRION (June 4, 2015)

Other clearances for product code NTE

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  • K230402 — ENROUTE® Transcarotid Neuroprotection System (April 11, 2023)
  • K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (April 6, 2022)
  • K210282 — WIRION Embolic Protection System (March 3, 2021)
  • K200198 — WIRION (March 18, 2020)
  • K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (July 25, 2019)
  • K153485 — ENROUTE Transcarotid Neuroprotection System (March 10, 2016)
  • K153086 — RX ACCUNET Embolic Protection System (November 20, 2015)
  • K143570 — WIRION (June 4, 2015)
  • K143072 — ENROUTE Transcarotid Neuroprotection System (February 9, 2015)