Home / 510(k) Clearances / K213771

510(k) K213771

Merlin Aspiration System by Mivi Neurovascular, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
December 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Mivi Neurovascular, Inc.

  • K192558 — Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, (April 6, 2020)

Other clearances for product code DXE

  • K240078 — Fogarty Thru-Lumen Embolectomy Catheter (August 28, 2024)
  • K241330 — Fogarty Fortis Arterial Embolectomy Catheter (July 2, 2024)
  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve (May 22, 2024)
  • K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (May 20, 2024)
  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
  • K163353 — Needle's Eye Snare Retrieval Set - 54cm (July 11, 2017)
  • K152335 — Export Advance Aspiration Catheter (September 18, 2015)