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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CVX-300 Excimer Laser; ELCA Coronary Laser Atherectomy Catheters
Classification Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Product Code: LPC
Device Class: 3
Registered Establishment Name: SPECTRANETICS CORP.
Registered Establishment Number: 1721279
Owner/Operator: SPECTRANETICS CORP.
Owner/Operator Number: 1721279
Establishment Operations: Manufacturer; Remanufacturer
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