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510(k) K924980

CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH by Endosonics Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
October 1, 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

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  • K962293 — ENDOSONICS AUTOMATIC PULL BACK DEVICE (September 16, 1996)
  • K950276 — MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUN (September 22, 1995)
  • K944004 — VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) (May 4, 1995)
  • K926252 — CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY (October 25, 1993)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)

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