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510(k) K961716

VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE by Ideas For Medicine, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1996
Date Received
May 2, 1996
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)
  • 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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