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510(k) K924125

CRI ELECTRONIC CONTROL SYSTEM by Catheter Research C/O Burditt, Bowles & Radzius — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
August 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

Other clearances by Catheter Research C/O Burditt, Bowles & Radzius

  • K924227 — CRI CYNOSAR CATHETER (June 29, 1993)
  • K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (January 10, 1992)
  • K904785 — CRI CYNOSAR CATHETER (March 6, 1991)
  • K904787 — CRI STEERABLE CATHETER CONTROL SYSTEM (December 17, 1990)
  • K900320 — CRI CYNOSAR CATHETER (September 14, 1990)
  • K884337 — MICRO-GUIDE SYSTEM (January 5, 1989)
  • K870700 — MICRO-GUIDE (December 3, 1987)

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