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510(k) K921750

CVIS INSIGHT III SYSTEM by Cardiovascular Imaging Systems, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1992
Date Received
April 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
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)
  • 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)

Other clearances for product code ITX

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  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)