Comaneci, Comaneci Petit, Comaneci 17

Temporary Coil Embolization Assist Device

Rapid-Medical Ltd.

The following data is part of a De Novo classification by Rapid-medical Ltd. with the FDA for Comaneci, Comaneci Petit, Comaneci 17.

Pre-market Notification Details

DeNovo IDDEN170064
Device Name:Comaneci, Comaneci Petit, Comaneci 17
ClassificationTemporary Coil Embolization Assist Device
Applicant Rapid-Medical Ltd. carmel Building pob 337 Yokneam,  IL 2069205
ContactOrit Yaniv
Product CodePUU  
CFR Regulation Number882.5955 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardNeurology
Classification AdvisoryNeurology
Date Received2017-09-28
Decision Date2019-04-24
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases


Device IdentifiersubmissionNumberSupplement
27290015107154 DEN170064 000
07290015107143 DEN170064 000
07290015107136 DEN170064 000

© 2020
This site is not affiliated with or endorsed by the FDA.