Company · US
Imperative Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K261176 | Zoom 4S Catheter Imperative Care, Inc. | QJP |
| Oct 30, 2025 | K252046 | Zoom System (Zoom 4S Catheter) Imperative Care, Inc. | NRY |
| Aug 28, 2025 | K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System Imperative Care, Inc. | QEW |
| Aug 26, 2025 | K244061 | X-Wire Guidewire Imperative Care, Inc. | MOF |
| May 28, 2025 | K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing Imperative Care, Inc. | NRY |
| May 14, 2025 | K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System Imperative Care, Inc. | QEW |
| Jan 14, 2025 | K242672 | Zoom System Imperative Care, Inc. | NRY |
| Jun 6, 2024 | K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support Imperative Care, Inc. | QJP |
| Apr 2, 2024 | K233975 | Zoom 6F Insert Catheters Imperative Care, Inc. | DQO |
| May 22, 2023 | K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support Imperative Care, Inc. | QJP |
| May 17, 2022 | K220807 | Imperative Care Radial 088 Access System Imperative Care, Inc. | QJP |
| Sep 20, 2021 | K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform Imperative Care, Inc. | QJP |
| Jun 8, 2021 | K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing Imperative Care, Inc. | NRY |
| Apr 23, 2021 | K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Imperative Care, Inc. | NRY |
| Mar 3, 2021 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform Imperative Care, Inc. | QJP |
| Sep 2, 2020 | K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Imperative Care, Inc. | NRY |
| Apr 17, 2019 | K183043 | 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Cathete Imperative Care, Inc. | NRY |
| Aug 8, 2018 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, E Imperative Care, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | IMPERATIVE CARE INC Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures. Completed |
NRY | K183043 K202182 +1 |