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510(k) K081626

FLOWPICC CONSOLE by Vasonova, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2008
Date Received
June 10, 2008
Clearance Type
Traditional
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.

  • K123813 — VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE (January 18, 2013)
  • K103255 — VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET (February 18, 2011)
  • K103260 — VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE (February 18, 2011)
  • K091924 — VPS CATHETER (November 18, 2009)
  • K083920 — FLOWPICC CATHETER (May 1, 2009)
  • K082481 — FLOWPICC CATHETER (December 17, 2008)
  • K081625 — FLOWPICC STYLET (September 26, 2008)

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