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510(k) K910281

INTRAVASCULAR IMAGING SYSTEM/MODIFIED by Intertherapy, Inc. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1991
Date Received
January 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

Other clearances by Intertherapy, Inc.

  • K913763 — INTERPRET(TM) CATHETER LINEAR TRANSLATOR (November 20, 1991)
  • K912600 — INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER (November 19, 1991)
  • K900305 — INTRAVASCULAR IMAGING SYSTEMS (April 20, 1990)
  • K895159 — INTRAVASCULAR IMAGING SYSTEM (March 12, 1990)

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