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510(k) K924227

CRI CYNOSAR CATHETER by Catheter Research C/O Burditt, Bowles & Radzius — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1993
Date Received
August 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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

  • K924125 — CRI ELECTRONIC CONTROL SYSTEM (May 26, 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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  • K192422 — Steerable Introducer 12F (October 4, 2019)
  • K190167 — MitraClip G4 Steerable Guide Catheter (May 29, 2019)