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510(k) K031361

CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP by Deltec, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2003
Date Received
April 30, 2003
Clearance Type
Special
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 Deltec, Inc.

  • K030983 — TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X (April 25, 2003)
  • K022221 — TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS (January 30, 2003)
  • K021999 — GRIPPER PLUS NEEDLE (August 13, 2002)
  • K020655 — DELTEC INSULIN INFUSION PUMP AND ACCESSORIES (August 13, 2002)

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