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FDA 510(k), K152829, Visions PV.014P RX Digital IVUS Catheter
FDA 510(k), K152829, Visions PV.014P RX Digital IVUS Catheter
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510(K) Number: K152829
Device Name: Visions PV.014P RX Digital IVUS Catheter
Manufacturer: Mary Stanners
Device Classification Name: Catheter, Ultrasound, Intravascular
Regulation Number: OBJ
Classification Product Code: KXA
Date Received: 09/29/2015
Decision Date: 11/19/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Visions PV.014P RX Digital IVUS Catheter
Manufacturer: Mary Stanners
Device Classification Name: Catheter, Ultrasound, Intravascular
Regulation Number: OBJ
Classification Product Code: KXA
Date Received: 09/29/2015
Decision Date: 11/19/2015
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
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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