IMPERATIVE CARE INC

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
17
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2577-2021Class IImperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mAugust 13, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K252046Zoom System (Zoom 4S Catheter)October 30, 2025
K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemAugust 28, 2025
K244061X-Wire GuidewireAugust 26, 2025
K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingMay 28, 2025
K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemMay 14, 2025
K242672Zoom SystemJanuary 14, 2025
K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupJune 6, 2024
K233975Zoom 6F Insert CathetersApril 2, 2024
K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupMay 22, 2023
K220807Imperative Care Radial 088 Access SystemMay 17, 2022
K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformSeptember 20, 2021
K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingJune 8, 2021
K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingApril 23, 2021
K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal PlatformMarch 3, 2021
K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingSeptember 2, 2020
K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRayApril 17, 2019
K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071August 8, 2018