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510(k) K113363

ANGIOJET SOLENT DISTA THROMBECTOMY SET by Medrad, Inc. — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
November 15, 2011
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 Medrad, Inc.

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  • K130637 — JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYST (April 10, 2013)
  • K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETST (October 19, 2012)
  • K113133 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 AR (December 15, 2011)
  • K113428 — ANGIOJET ULTRA DVX THROMBECTOMY SET (December 2, 2011)
  • K112086 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 AR (October 14, 2011)
  • K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET (May 24, 2011)
  • K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRAT (June 23, 2010)
  • K082905 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC (January 12, 2009)

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)