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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Angiosculpt PTCA scoring balloon
Classification Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Product Code: NWX
Device Class: 3
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: P050018
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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