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FDA 510(k), K112219, TAPAS CATHETER
FDA 510(k), K112219, TAPAS CATHETER
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510(K) Number: K112219
Device Name: TAPAS CATHETER
Manufacturer: THOMAS SCHROEDER
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: 08/02/2011
Date Received: 11/18/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TAPAS CATHETER
Manufacturer: THOMAS SCHROEDER
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: 08/02/2011
Date Received: 11/18/2011
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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