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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

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)
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

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)