FDA 510(k), K150709, ProTrack RF Anchor Wire
FDA 510(k), K150709, ProTrack RF Anchor Wire
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510(K) Number: K150709
Device Name: ProTrack RF Anchor Wire
Manufacturer: BAYLIS MEDICAL COMPANY INC.
Device Classification Name: Catheter, Septostomy
Regulation Number: 870.5175
Classification Product Code: DXF
Date Received: 03/19/2015
Decision Date: 06/17/2015
Regulation Medical Specialty: Cardiovascular
Device Name: ProTrack RF Anchor Wire
Manufacturer: BAYLIS MEDICAL COMPANY INC.
Device Classification Name: Catheter, Septostomy
Regulation Number: 870.5175
Classification Product Code: DXF
Date Received: 03/19/2015
Decision Date: 06/17/2015
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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