FDA 510(k), K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter
FDA 510(k), K171277, Reprocessed Inquiry Steerable Diagnostic EP Catheter
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
Total pages: 2,735
Fully redacted pages: 2,702
Content pages: 33
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