The following data is part of a premarket notification filed by Renalpro Medical, Inc. with the FDA for Aortastat Occlusion Device.
| Device ID | K210602 |
| 510k Number | K210602 |
| Device Name: | AortaSTAT Occlusion Device |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | RenalPro Medical, Inc. 2370-B Walsh Avenue Santa Clara, CA 95051 |
| Contact | James Twitchell |
| Correspondent | Roberta Hines Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, WA 98077 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-07-09 |