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510(k) K945298

SMARTFLOW I ADMINISTRATION SET by River Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1995
Date Received
October 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by River Medical, Inc.

  • K023174 — DISPOSABLE TEMPORARY PACING WIRE (June 11, 2003)
  • K944351 — SMARTDOSE IV PREFILLED INFUSION CONTAINER (November 15, 1995)
  • K944352 — SMARTDOSE III INFUSION CONTAINER (November 15, 1995)
  • K943692 — SMART DOSE(TM) (April 28, 1995)
  • K932895 — RIVER PUMP (March 31, 1994)
  • K933335 — RIVER VIAL ADAPTER (March 1, 1994)
  • K915120 — TEF/PLATINUM PISTON (December 27, 1991)
  • K915121 — TEF/WIRE PISTON (December 23, 1991)
  • K913286 — H/A TOTAL-REGULAR, H/A TOTAL-OFFSET (December 18, 1991)
  • K913287 — H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET (December 18, 1991)

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