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FDA 510(k), K121273, VISIONS PV .035 DITITAL IVUS CATHETER
FDA 510(k), K121273, VISIONS PV .035 DITITAL IVUS CATHETER
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510(K) Number: K121273
Device Name: VISIONS PV .035 DITITAL IVUS CATHETER
Manufacturer: MARILYN POURAZAR
Device Classification Name: Catheter, Ultrasound, Intravascular
Regulation Number: OBJ
Classification Product Code: 04/27/2012
Date Received: 09/10/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VISIONS PV .035 DITITAL IVUS CATHETER
Manufacturer: MARILYN POURAZAR
Device Classification Name: Catheter, Ultrasound, Intravascular
Regulation Number: OBJ
Classification Product Code: 04/27/2012
Date Received: 09/10/2012
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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