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510(k) K864062

PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) by Ideas For Medicine, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1987
Date Received
October 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Ideas For Medicine, Inc.

  • K961883 — VERSA-CATH ARTERIAL CATHETER (January 13, 1997)
  • K962751 — IDEAS' DUAL PORT (September 30, 1996)
  • 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)
  • K935023 — GODAT UTERINE MANIPULATOR INJECTOR (January 4, 1995)
  • K935964 — IDEAS OCCLUDER (January 4, 1995)
  • K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (May 25, 1988)
  • K872090 — THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (October 30, 1987)

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