The following data is part of a De Novo classification by Rapid-medical Ltd. with the FDA for Comaneci, Comaneci Petit, Comaneci 17.
| DeNovo ID | DEN170064 |
| Device Name: | Comaneci, Comaneci Petit, Comaneci 17 |
| Classification | Temporary Coil Embolization Assist Device |
| Applicant | Rapid-Medical Ltd. carmel Building pob 337 Yokneam, IL 2069205 |
| Contact | Orit Yaniv |
| Product Code | PUU |
| CFR Regulation Number | 882.5955 [🔎] |
| 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 | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2017-09-28 |
| Decision Date | 2019-04-24 |
| 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 Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290015107154 | DEN170064 | 000 |
| 07290015107143 | DEN170064 | 000 |
| 07290015107136 | DEN170064 | 000 |