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510(k) K921879

CBIS CATHETER PULL-BACK DEVICE by Cardiovascular Imaging Systems, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1992
Date Received
April 20, 1992
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.

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  • 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)
  • 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)
  • K921147 — CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE (June 16, 1992)

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