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FDA 510(k), K152127, CorMatrix Tyke
FDA 510(k), K152127, CorMatrix Tyke
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$149.00 USD
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510(K) Number: K152127
Device Name: CorMatrix Tyke
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 07/31/2015
Decision Date: 02/04/2016
Regulation Medical Specialty: Cardiovascular
Device Name: CorMatrix Tyke
Manufacturer: CORMATRIX CARDIOVASCULAR, INC.
Device Classification Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation Number: 870.3470
Classification Product Code: DXZ
Date Received: 07/31/2015
Decision Date: 02/04/2016
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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