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Imperative Care, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories6
Latest FDA decision2025-10-30
TypeNumberDevice NameCodeDateActions
510(k) K252046 Zoom System (Zoom 4S Catheter)NRY2025-10-30 View
510(k) K252057 Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemQEW2025-08-28 View
510(k) K244061 X-Wire GuidewireMOF2025-08-26 View
510(k) K243047 Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRY2025-05-28 View
510(k) K250775 Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemQEW2025-05-14 View
510(k) K242672 Zoom SystemNRY2025-01-14 View
510(k) K240948 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupportQJP2024-06-06 View
510(k) K233975 Zoom 6F Insert CathetersDQO2024-04-02 View
510(k) K231168 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupportQJP2023-05-22 View
510(k) K220807 Imperative Care Radial 088 Access SystemQJP2022-05-17 View
510(k) K212224 TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformQJP2021-09-20 View
510(k) K211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingNRY2021-06-08 View
510(k) K210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRY2021-04-23 View
510(k) K203764 TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal PlatformQJP2021-03-03 View
510(k) K202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRY2020-09-02 View
510(k) K183043 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion CatheterNRY2019-04-17 View
510(k) K180169 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm LengthDQY2018-08-08 View

Related Clinical Trials

NCT06062329SYMPHONY-PE Study for Treatment of Pulmonary EmbolismCOMPLETEDNCT07350499Aspiration Thrombectomy Using the Symphony or Prodigy SystemRECRUITINGNCT07491952Continuous Dual Aspiration Technique With Zoom System for StrokeRECRUITING
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