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510(k) K053372

LBI CATHETER SYSTEM by Lumen Biomedical, Inc. — Product Code QEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2006
Date Received
December 5, 2005
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 Lumen Biomedical, Inc.

  • K111987 — FIBERNET EMBOLIC PROTECTION DEVICE (August 17, 2011)
  • K082348 — FIBERNET EMBOLIC PROTECTION SYSTEM (November 18, 2008)
  • K080901 — LBI EMBOLECTOMY SYSTEM (October 2, 2008)
  • K071529 — XTRACT CATHETER SYSTEM (August 10, 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)