FDA 510(k), K183353, Telescope Guide Extension Catheter
FDA 510(k), K183353, Telescope Guide Extension Catheter
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510(K) Number: K183353
Device Name: Telescope Guide Extension Catheter
Manufacturer: Medtronic Inc.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 12/03/2018
Decision Date: 03/22/2019
Regulation Medical Specialty: Cardiovascular
Device Name: Telescope Guide Extension Catheter
Manufacturer: Medtronic Inc.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 12/03/2018
Decision Date: 03/22/2019
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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