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FDA 510(k), K073326, NRG TRANSSEPTAL NEEDLE
FDA 510(k), K073326, NRG TRANSSEPTAL NEEDLE
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510(K) Number: K073326
Device Name: NRG TRANSSEPTAL NEEDLE
Manufacturer: MEGHAL KHAKHAR
Device Classification Name: Catheter, Septostomy
Regulation Number: DXF
Classification Product Code: 11/27/2007
Date Received: 05/28/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: NRG TRANSSEPTAL NEEDLE
Manufacturer: MEGHAL KHAKHAR
Device Classification Name: Catheter, Septostomy
Regulation Number: DXF
Classification Product Code: 11/27/2007
Date Received: 05/28/2008
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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