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510(k) K990271

ENDOSONICS TRAK BACK DEVICE by Endosonics Corp. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
January 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
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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