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510(k) K970049

BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ by Cardiovascular Imaging Systems, Inc. — Product Code ITX

K970049 is an FDA 510(k) premarket notification submitted by Cardiovascular Imaging Systems, Inc. for the device "BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/". The FDA issued a decision of Substantially Equivalent on June 20, 1997. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Cardiovascular Imaging Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1997
Date Received
January 6, 1997
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.

  • 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)
  • K921147 — CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE (June 16, 1992)
  • K921148 — CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE (June 16, 1992)

Other clearances for product code ITX

  • K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (September 18, 2025)
  • 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)

FDA data resources