The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Tracstar Ldp Large Distal Platform; Zoom 88 Large Distal Platform.
| Device ID | K212224 |
| 510k Number | K212224 |
| Device Name: | TracStar LDP Large Distal Platform; Zoom 88 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812212030368 | K212224 | 000 |
| 00812212030351 | K212224 | 000 |
| 00812212030344 | K212224 | 000 |
| 00812212030337 | K212224 | 000 |
| 00812212030467 | K212224 | 000 |
| 00812212030405 | K212224 | 000 |
| 00812212030399 | K212224 | 000 |