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510(k) K042117

PROXIS SYSTEM, MODEL EPS 101 by Velocimed, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2005
Date Received
August 5, 2004
Clearance Type
Special
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, Inc.

  • K052523 — PROXIS SYSTEM (September 7, 2006)
  • K043084 — PREMERE DELIVERY SHEATH, MODEL PDS (May 2, 2005)
  • K042910 — VENTURE WIRE CONTROL CATHETER, MODEL WCC (November 22, 2004)
  • K040922 — VENTURE WIRE CONTROL CATHETER (August 18, 2004)
  • K023548 — PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 (August 4, 2003)

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