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510(k) K052428

RESOLUTION ENDOVASCULAR SYSTEM by Omnisonics Medical Technologies — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2005
Date Received
September 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mechanical Thrombolysis Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

Other clearances by Omnisonics Medical Technologies

  • K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM (December 15, 2008)
  • K071762 — OMNIWAVE ENDOVASCULAR SYSTEM (September 27, 2007)
  • K041705 — RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 (September 1, 2004)
  • K003824 — OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI (March 8, 2001)
  • K993628 — OMNISONICS ULTRASONIC PROBES (December 15, 1999)
  • K993445 — OMNISONIC ENDOSCOPIC DEFLECTOR (December 6, 1999)
  • K991377 — OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER (July 12, 1999)

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