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FDA 510(k), K163345, TVC Imaging System, TVC Catheter
FDA 510(k), K163345, TVC Imaging System, TVC Catheter
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510(K) Number: K163345
Device Name: TVC Imaging System, TVC Catheter
Manufacturer: Stephen Sum
Device Classification Name: Catheter, Intravascular, Plaque Morphology Evaluation
Regulation Number: OGZ
Classification Product Code: KXA
Date Received: 11/29/2016
Decision Date: 06/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TVC Imaging System, TVC Catheter
Manufacturer: Stephen Sum
Device Classification Name: Catheter, Intravascular, Plaque Morphology Evaluation
Regulation Number: OGZ
Classification Product Code: KXA
Date Received: 11/29/2016
Decision Date: 06/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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