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510(k) K962293

ENDOSONICS AUTOMATIC PULL BACK DEVICE by Endosonics Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1996
Date Received
June 14, 1996
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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  • 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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