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510(k) K071762

OMNIWAVE ENDOVASCULAR SYSTEM by Omnisonics Medical Technologies — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2007
Date Received
June 29, 2007
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)
  • 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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  • K241851 — Versus™ Catheter (VS110-8B) (November 25, 2024)
  • K231653 — BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (July 3, 2023)
  • K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
  • K220866 — EKOS+ Endovascular Device (April 20, 2022)
  • K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device (December 14, 2021)
  • K211080 — EkoSonic Endovascular Device (November 19, 2021)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 2021)
  • K202347 — UNIFUSE Infusion System with Cooper Wire (September 15, 2020)