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510(k) K033686

PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM by Smiths Medical MD, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2004
Date Received
November 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

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  • K101180 — GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MOD (August 3, 2010)
  • K091181 — LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS (June 12, 2009)
  • K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE (December 17, 2008)
  • K081156 — CADD MEDICATION CASSETTE RESERVOIR (July 18, 2008)
  • K080743 — LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP (April 25, 2008)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K072955 — CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CAR (February 13, 2008)
  • K072657 — POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS A (December 14, 2007)

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