FDA 510(k), K050114, SUPERCATH Z3V

FDA 510(k), K050114, SUPERCATH Z3V

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510(K) Number: K050114
Device Name: SUPERCATH Z3V
Manufacturer: KOZO NAGAYAMAB
Device Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation Number: FOZ
Classification Product Code: KXA
Date Received: 01/18/2005
Decision Date: 06/09/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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