FDA 510(k), K181038, CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
FDA 510(k), K181038, CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
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$149.00 USD
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510(K) Number: K181038
Device Name: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
Manufacturer: CorMatrix Cardiovascular, Inc.
Device Classification Name: Intracardiac Patch Or Pledget, Biologically Derived
Regulation Number: 870.3470
Classification Product Code: PSQ
Date Received: 04/19/2018
Decision Date: 10/10/2018
Regulation Medical Specialty: Cardiovascular
Device Name: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
Manufacturer: CorMatrix Cardiovascular, Inc.
Device Classification Name: Intracardiac Patch Or Pledget, Biologically Derived
Regulation Number: 870.3470
Classification Product Code: PSQ
Date Received: 04/19/2018
Decision Date: 10/10/2018
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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