Home / 510(k) Clearances / K023548

510(k) K023548

PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 by Velocimed — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2003
Date Received
October 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Velocimed

  • K052523 — PROXIS SYSTEM (September 7, 2006)
  • K043084 — PREMERE DELIVERY SHEATH, MODEL PDS (May 2, 2005)
  • K042117 — PROXIS SYSTEM, MODEL EPS 101 (January 7, 2005)
  • K042910 — VENTURE WIRE CONTROL CATHETER, MODEL WCC (November 22, 2004)
  • K040922 — VENTURE WIRE CONTROL CATHETER (August 18, 2004)

Other clearances for product code DQY

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
  • K250147 — CPS Locator 3D Delivery Catheter (August 22, 2025)
  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)