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FDA 510(k), K171897, Approach CTO Microwire Guide
FDA 510(k), K171897, Approach CTO Microwire Guide
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510(K) Number: K171897
Device Name: Approach CTO Microwire Guide
Manufacturer: Cook Incorporated
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 06/26/2017
Decision Date: 08/21/2017
Regulation Medical Specialty: Cardiovascular
Device Name: Approach CTO Microwire Guide
Manufacturer: Cook Incorporated
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 06/26/2017
Decision Date: 08/21/2017
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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