CARPEDIEM System

Pediatric Hemodialysis System

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

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