Imperative Care, Inc.
Medical device manufacturer in Campbell, CA.
18510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261176 | Zoom 4S CatheterQJP · Traditional | 08/28/2026SE |
| K252046 | Zoom System (Zoom 4S Catheter)NRY · Traditional | 10/30/2025SE |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy SystemQEW · Traditional | 08/28/2025SE |
| K244061 | X-Wire GuidewireMOF · Traditional | 08/26/2025SE |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRY · Traditional | 05/28/2025SE |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy SystemQEW · Special | 05/14/2025SE |
| K242672 | Zoom SystemNRY · Traditional | 01/14/2025SE |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Traditional | 06/06/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | 04/02/2024SE |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Special | 05/22/2023SE |
| K220807 | Imperative Care Radial 088 Access SystemQJP · Traditional | 05/17/2022SE |
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformQJP · Special | 09/20/2021SE |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingNRY · Special | 06/08/2021SE |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRY · Special | 04/23/2021SE |
| K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…QJP · Traditional | 03/03/2021SE |
| K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRY · Special | 09/02/2020SE |
| K183043 | 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045…NRY · Traditional | 04/17/2019SE |
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…DQY · Traditional | 08/08/2018SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2577-2021 Class I | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F…There is a potential for distal end of catheters to fracture and become detached. | 08/13/2021Completed |