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FDA 510(k), K161384, Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
FDA 510(k), K161384, Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
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510(K) Number: K161384
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: 05/19/2016
Decision Date: 09/14/2016
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: 05/19/2016
Decision Date: 09/14/2016
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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