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FDA 510(k), K180454, Shockwave Medical Intravascular Lithotripsy (IVL) System
FDA 510(k), K180454, Shockwave Medical Intravascular Lithotripsy (IVL) System
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$89.00 USD
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510(K) Number: K180454
Device Name: Shockwave Medical Intravascular Lithotripsy (IVL) System
Manufacturer: Plessy Paul
Device Classification Name: Percutaneous Catheter, Ultrasound
Regulation Number: PPN
Classification Product Code: KXA
Date Received: 02/20/2018
Decision Date: 06/27/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Shockwave Medical Intravascular Lithotripsy (IVL) System
Manufacturer: Plessy Paul
Device Classification Name: Percutaneous Catheter, Ultrasound
Regulation Number: PPN
Classification Product Code: KXA
Date Received: 02/20/2018
Decision Date: 06/27/2018
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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