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510(k) K112887

UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR by Upstream Peripheral Technologies — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2012
Date Received
September 30, 2011
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 Upstream Peripheral Technologies

  • K211802 — GoBack Crossing Catheter (March 1, 2022)
  • K182937 — Upstream GoBack Crossing Catheter (May 23, 2019)
  • K120964 — UPSTREAM GR CATHETER (May 25, 2012)
  • K112886 — UPSTREAM SUPPORT CATHETER (February 23, 2012)

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