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510(k) K080806

ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 by Possis Medical, Inc. — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2008
Date Received
March 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspiration Thrombectomy Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Other clearances by Possis Medical, Inc.

  • K133629 — ANGIOJET ULTRA AVX THROMBECTOMY SET (February 14, 2014)
  • K091593 — ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS (June 22, 2009)
  • K090253 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR T (April 8, 2009)
  • K082382 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (December 12, 2008)
  • K081989 — MODIFICATION TO FETCH ASPIRATION CATHETER (September 26, 2008)
  • K081454 — GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE (June 13, 2008)
  • K073441 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (January 24, 2008)
  • K072769 — ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY S (November 14, 2007)
  • K072269 — ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 (September 8, 2007)
  • K071336 — ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (August 24, 2007)

Other clearances for product code QEZ

  • K253925 — Aventus Thrombectomy System (January 15, 2026)
  • K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885 (November 24, 2025)
  • K251312 — Vesalio Peripheral System (October 24, 2025)
  • K251488 — FLOWRUNNER Aspiration System (July 14, 2025)
  • K243549 — JETi Hydrodynamic Thrombectomy System (April 4, 2025)
  • K250013 — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP (March 24, 2025)
  • K240397 — AlphaVac MMA F1885 System (H787253020) (April 1, 2024)
  • K232458 — JETi™Hydrodynamic Thrombectomy System (December 19, 2023)
  • K213388 — AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (April 4, 2022)
  • K213565 — JETi AIO Peripheral Thrombectomy System (February 1, 2022)