The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Tracstar Large Distal Platform, Zoom 88 Large Distal Platform, Zoom 88-t Large Distal Platform.
| Device ID | K203764 |
| 510k Number | K203764 |
| Device Name: | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 |
| Contact | Kristin Ellis |
| 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 | 2020-12-23 |
| Decision Date | 2021-03-03 |