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FDA 510(k), K213898, ProTrack Pigtail Wire
FDA 510(k), K213898, ProTrack Pigtail Wire
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$149.00 USD
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$149.00 USD
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510(K) Number: K213898
Device Name: ProTrack Pigtail Wire
Manufacturer: May Tsai
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: 12/14/2021
Date Received: 03/01/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ProTrack Pigtail Wire
Manufacturer: May Tsai
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: 12/14/2021
Date Received: 03/01/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- 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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