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510(k) K832906

PORT-A-CATH IMPLANTABLE CATHETER SYS by Pharmacia, Inc. — Product Code LLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
August 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K941993 — PHARMACIA CAP SYSTEM PHADIATOP FEIA (January 30, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)

Other clearances for product code LLD

  • K880072 — PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM (March 29, 1988)
  • K864552 — PORT-A-CATH IMPLANTABLE CATHETER SYSTEM (March 31, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)