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510(k) K963290

COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM by Endosonics Corp. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1997
Date Received
August 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
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)
  • K924980 — CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH (January 15, 1993)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)

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