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510(k) K043084

PREMERE DELIVERY SHEATH, MODEL PDS by Velocimed, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2005
Date Received
November 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Velocimed, Inc.

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  • 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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