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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 Catheter - Easy Exchange (EX); AngioSculpt PTCA Scoring Balloon Catheter - Over-the-Wire (OTW); AngioSculpt PTCA Scoring Balloon Catheter - Rapid Exchange (RX); Catheter percutaneous transluminal coronary angioplasty PTCA cutting/scoring AngioSculpt PTCA Scoring Balloon Catheter
Classification Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Product Code: NWX
Device Class: 3
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1721676
Owner/Operator: Sterigenics International, LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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