FDA 510(k), K993191, TFX MEDICAL INTRODUCER ASSEMBLY

FDA 510(k), K993191, TFX MEDICAL INTRODUCER ASSEMBLY

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510(K) Number: K993191
Device Name: TFX MEDICAL INTRODUCER ASSEMBLY
Manufacturer: TFX MEDICAL, INC.
Device Classification Name: introducer, catheter
Regulation Number: 870.1340
Classification Product Code: DYB
Date Received: 09/23/1999
Decision Date: 03/24/2000
Regulation Medical Specialty: Cardiovascular
  • 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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