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510(k) K905625

CVIS INSIGHT IMAGING CATHETER by Cardiovascular Imaging Systems, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
December 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Cardiovascular Imaging Systems, Inc.

  • K970049 — BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULT (June 20, 1997)
  • K942231 — MICROVIEW II/MICRORAIL II CATHETERS (August 1, 1994)
  • K933517 — AUTOMATIC PULL BACK DEVICE (October 15, 1993)
  • K930232 — CVIS INSIGHT IMAGING GUIDE CATHETER (July 21, 1993)
  • K924922 — CVIS INSIGHT IMAGING CATHETER (June 29, 1993)
  • K930311 — CVIS LONGVIEW (June 2, 1993)
  • K921879 — CBIS CATHETER PULL-BACK DEVICE (July 16, 1992)
  • K921750 — CVIS INSIGHT III SYSTEM (July 13, 1992)
  • K921631 — CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL (July 2, 1992)
  • K921148 — CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE (June 16, 1992)

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