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510(k) K123813

VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE by Vasonova, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2013
Date Received
December 11, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Other clearances by Vasonova, Inc.

  • K103260 — VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE (February 18, 2011)
  • K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET (February 18, 2011)
  • K091924 — VPS CATHETER (November 18, 2009)
  • K083920 — FLOWPICC CATHETER (May 1, 2009)
  • K082481 — FLOWPICC CATHETER (December 17, 2008)
  • K081626 — FLOWPICC CONSOLE (October 15, 2008)
  • K081625 — FLOWPICC STYLET (September 26, 2008)

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