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510(k) K073519

QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 by Kensey Nash Corp. — Product Code QEZ

K073519 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "QUICKCAT EXTRACTION CATHETER, MODEL 60090-01". The FDA issued a decision of Substantially Equivalent on March 28, 2008. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Kensey Nash Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2008
Date Received
December 14, 2007
Clearance Type
Special
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 Kensey Nash Corp.

  • K103787 — MEDEOR MATRIX (February 7, 2011)
  • K091192 — KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX (November 2, 2009)
  • K091499 — MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) (October 22, 2009)
  • K090919 — KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (October 2, 2009)
  • K071695 — KENSEY NASH MACROPORE SHIELD (December 31, 2007)
  • K072384 — MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE (September 21, 2007)
  • K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM (August 23, 2007)
  • K071237 — COPIOS BONE VOID FILLER SPONGE AND PASTE (June 1, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)

Other clearances for product code QEZ

  • K262030 — Aventus Thrombectomy System (July 15, 2026)
  • K253589 — Liberant™ RX Aspiration Catheter (April 23, 2026)
  • K254208 — FLOWRUNNER Aspiration System (March 20, 2026)
  • 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)

FDA data resources