The following data is part of a premarket notification filed by Neurescue Aps with the FDA for Neurescue Device.
| Device ID | K210358 |
| 510k Number | K210358 |
| Device Name: | Neurescue Device |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Neurescue Aps Kobmagergade 53, 2 Copenhagen, DK 1150 |
| Contact | Habib Forest |
| Correspondent | Semih Oktay CardioMed Device Consultants, LLC 1783 Forest Drive Suite 254 Annapolis, MD 21401 |
| Product Code | MJN |
| Subsequent Product Code | DQO |
| Subsequent Product Code | DQY |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-05-21 |