510(k) Premarket Notification

• Device Classification Name: dialyzer, high permeability with or without sealed dialysate system
• 510(k) Number: K193542
• Device Name: Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
• Applicant: Bellco Srl; Via Camurana 1; Mirandola, IT 41037
• Applicant Contact: Rekha Roveri
• Correspondent: Medtronic, Inc.; 710 Medtronic Parkway (LT140); Minneapolis, MN 55432
• Correspondent Contact: Michele Gust
• Regulation Number: 876.5860
• Classification Product Code: KDI
• Date Received: 12/20/2019
• Decision Date: 10/08/2020
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Gastroenterology/Urology
• 510k Review Panel: Gastroenterology/Urology
• Summary: Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No