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510(k) K000942

CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 by Sims Deltec, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2000
Date Received
March 23, 2000
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

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  • 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)
  • K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECU (February 12, 1999)
  • K984055 — CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS (January 29, 1999)

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