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FDA 510(k), K163306, Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
FDA 510(k), K163306, Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
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510(K) Number: K163306
Device Name: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
Manufacturer: Shockwave Medical, Inc.
Device Classification Name: percutaneous catheter, ultrasound
Regulation Number: 870.1250
Classification Product Code: PPN
Date Received: 11/23/2016
Decision Date: 12/22/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
Manufacturer: Shockwave Medical, Inc.
Device Classification Name: percutaneous catheter, ultrasound
Regulation Number: 870.1250
Classification Product Code: PPN
Date Received: 11/23/2016
Decision Date: 12/22/2016
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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