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510(k) K904785

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
October 22, 1990
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

  • K924227 — CRI CYNOSAR CATHETER (June 29, 1993)
  • K924125 — CRI ELECTRONIC CONTROL SYSTEM (May 26, 1993)
  • K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (January 10, 1992)
  • 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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  • K223824 — POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping (March 22, 2023)
  • K221397 — MitraClip G4 Steerable Guide Catheter (September 28, 2022)
  • K221044 — AcQGuide® VUE Steerable Sheath (May 5, 2022)
  • K211100 — AcQGuide MAX Steerable Sheath (May 14, 2021)
  • K202620 — FlexCath Advance Steerable Sheath and Dilator (November 13, 2020)
  • K192422 — Steerable Introducer 12F (October 4, 2019)
  • K190167 — MitraClip G4 Steerable Guide Catheter (May 29, 2019)