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510(k) K990083

CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER by Sims Deltec, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1999
Date Received
January 11, 1999
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 Sims Deltec, Inc.

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  • K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 (April 27, 2000)
  • K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (January 27, 2000)
  • K992697 — PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (November 18, 1999)
  • K992880 — P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM (October 19, 1999)
  • K991599 — CADD ADMINISTRATION SET (June 15, 1999)
  • K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPH (June 9, 1999)
  • K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (June 9, 1999)
  • K984055 — CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS (January 29, 1999)

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