The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Imperative Care Radial 088 Access System.
| Device ID | K220807 |
| 510k Number | K220807 |
| Device Name: | Imperative Care Radial 088 Access System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Contact | Kristin Elis |
| Correspondent | Kristin Ellis Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812212030566 | K220807 | 000 |
| 00812212030535 | K220807 | 000 |
| 00812212030528 | K220807 | 000 |
| 00812212030511 | K220807 | 000 |