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510(k) K872485

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) by Ideas For Medicine, Inc. — Product Code DXE

K872485 is an FDA 510(k) premarket notification submitted by Ideas For Medicine, Inc. for the device "CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)". The FDA issued a decision of Substantially Equivalent on August 12, 1987. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Ideas For Medicine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1987
Date Received
June 22, 1987
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)

Other clearances for product code DXE

  • K240078 — Fogarty Thru-Lumen Embolectomy Catheter (August 28, 2024)
  • K241330 — Fogarty Fortis Arterial Embolectomy Catheter (July 2, 2024)
  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve (May 22, 2024)
  • K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (May 20, 2024)
  • K213771 — Merlin Aspiration System (January 27, 2022)
  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
  • K163353 — Needle's Eye Snare Retrieval Set - 54cm (July 11, 2017)

FDA data resources