CARPEDIEM System

Pediatric Hemodialysis System

Bellco Srl (now Part Of Medtronic, Inc)

The following data is part of a De Novo classification by Bellco Srl (now Part Of Medtronic, Inc) with the FDA for Carpediem System.

Pre-market Notification Details

• DeNovo ID: DEN180055
• Device Name: CARPEDIEM System
• Classification: Pediatric Hemodialysis System
• Applicant: Bellco Srl (now Part Of Medtronic, Inc) via Camurana 1 Mirandola, IT 41037
• Contact: Matteo Chiappini
• Product Code: QIR
• CFR Regulation Number: 876.5861 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Gastroenterology/Urology
• Classification Advisory: Gastroenterology/Urology
• Type: Direct
• Date Received: 2018-10-09
• Decision Date: 2020-04-29
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
38032979792283	DEN180055	000
38032979792290	DEN180055	000
08051736003652	DEN180055	000
08051736007476	DEN180055	000