Medical Device Manufacturer · US , Sunnyvale , CA

Imperative Care, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2018
17
Total
17
Cleared
0
Denied

Imperative Care, Inc. has 17 FDA 510(k) cleared neurology devices. Based in Sunnyvale, US.

Latest FDA clearance: Oct 2025. Active since 2018.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

2 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Imperative Care, Inc.
17 devices
1-17 of 17
Cleared Oct 30, 2025
Zoom System (Zoom 4S Catheter)
K252046 · NRY
Neurology · 122d
Cleared CT Aug 28, 2025
Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System
K252057 · QEW
Cardiovascular · 58d
Cleared Aug 26, 2025
X-Wire Guidewire
K244061 · MOF
Neurology · 238d
Cleared May 28, 2025
Zoom 7X Catheter
K243047 · NRY
Neurology · 243d
Cleared May 14, 2025
Symphony™ Thrombectomy System
K250775 · QEW
Cardiovascular · 61d
Cleared CT Jan 14, 2025
Zoom System
K242672 · NRY
Neurology · 130d
Cleared Jun 06, 2024
TracStar LDP Large Distal Platform
K240948 · QJP
Neurology · 59d
Cleared Apr 02, 2024
Zoom 6F Insert Catheters
K233975 · DQO
Cardiovascular · 109d
Cleared May 22, 2023
TracStar LDP Large Distal Platform
K231168 · QJP
Neurology · 27d
Cleared May 17, 2022
Imperative Care Radial 088 Access System
K220807 · QJP
Neurology · 60d
Cleared Sep 20, 2021
TracStar LDP Large Distal Platform
K212224 · QJP
Neurology · 66d
Cleared Jun 08, 2021
ZOOM 71 Reperfusion Catheter
K211476 · NRY
Neurology · 27d
Cleared Apr 23, 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K210996 · NRY
Neurology · 21d
Cleared Mar 03, 2021
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T...
K203764 · QJP
Neurology · 70d
Cleared Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K202182 · NRY
Neurology · 29d
Cleared Apr 17, 2019
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion...
K183043 · NRY
Neurology · 166d
Cleared Aug 08, 2018
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay...
K180169 · DQY
Neurology · 198d
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