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510(k) K884337

MICRO-GUIDE SYSTEM by Catheter Research C/O Burditt, Bowles & Radzius — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1989
Date Received
October 14, 1988
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)
  • K904785 — CRI CYNOSAR CATHETER (March 6, 1991)
  • K904787 — CRI STEERABLE CATHETER CONTROL SYSTEM (December 17, 1990)
  • K900320 — CRI CYNOSAR CATHETER (September 14, 1990)
  • K870700 — MICRO-GUIDE (December 3, 1987)

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  • K232321 — FlexCath Contour™ Steerable Sheath (October 31, 2023)
  • 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)