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510(k) K083335

MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM by Omnisonics Medical Technologies — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2008
Date Received
November 12, 2008
Clearance Type
Special
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

  • K071762 — OMNIWAVE ENDOVASCULAR SYSTEM (September 27, 2007)
  • K052428 — RESOLUTION ENDOVASCULAR SYSTEM (December 8, 2005)
  • 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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