FDA 510(k), K150465, Medtronic Confida Brecker Guidewire

FDA 510(k), K150465, Medtronic Confida Brecker Guidewire

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K150465
Device Name: Medtronic Confida Brecker Guidewire
Manufacturer: Genevieve Balutowski Dunbar
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: KXA
Date Received: 02/23/2015
Decision Date: 08/03/2015
Decision: Substantially Equivalent (SESE)
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.

View full details