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510(k) K962751

IDEAS' DUAL PORT by Ideas For Medicine, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1996
Date Received
July 15, 1996
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

Other clearances by Ideas For Medicine, Inc.

  • K961883 — VERSA-CATH ARTERIAL CATHETER (January 13, 1997)
  • K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (September 19, 1996)
  • K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F (September 9, 1996)
  • K960422 — PRUITT SAFETY OCCLUSION CATHETER (August 7, 1996)
  • K954713 — DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) (July 24, 1996)
  • K935964 — IDEAS OCCLUDER (January 4, 1995)
  • K935023 — GODAT UTERINE MANIPULATOR INJECTOR (January 4, 1995)
  • K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (May 25, 1988)
  • K872090 — THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (October 30, 1987)
  • K872485 — CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) (August 12, 1987)

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