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FDA 510(k), K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter
FDA 510(k), K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter
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510(K) Number: K171277
Device Name: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Manufacturer: Innovative Health, LLC.
Device Classification Name: catheter, electrode recording, or probe, electrode recording
Regulation Number: 870.1220
Classification Product Code: DRF
Date Received: 05/01/2017
Decision Date: 10/23/2017
Regulation Medical Specialty: Cardiovascular
Device Name: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Manufacturer: Innovative Health, LLC.
Device Classification Name: catheter, electrode recording, or probe, electrode recording
Regulation Number: 870.1220
Classification Product Code: DRF
Date Received: 05/01/2017
Decision Date: 10/23/2017
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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