Medical Device Manufacturer · US , Sunnyvale , CA

Imperative Care, Inc.

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

Imperative Care, Inc. — FDA 510(k) Submissions

Imperative Care, Inc. has submitted 17 FDA 510(k) premarket notifications since 2018, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Thrombus Retriever, Catheter, Percutaneous, Neurovasculature, Peripheral Mechanical Thrombectomy With Aspiration, Guide, Wire, Catheter, Neurovasculature, Catheter, Percutaneous . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Zoom System (Zoom 4S Catheter)
K252046 · NRY Catheter, Thrombus Retriever · Neurology
Oct 2025 122d
Symphony? Thrombectomy System and Symphony? 16F 82cm Thrombectomy System
K252057 · QEW Peripheral Mechanical... · Cardiovascular
Aug 2025 58d
X-Wire Guidewire
K244061 · MOF Guide, Wire, Catheter,... · Neurology
Aug 2025 238d
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
K243047 · NRY Catheter, Thrombus Retriever · Neurology
May 2025 243d
Symphony? Thrombectomy System; Symphony? 16F 82cm Thrombectomy System
K250775 · QEW Peripheral Mechanical... · Cardiovascular
May 2025 61d
Zoom System
K242672 · NRY Catheter, Thrombus Retriever · Neurology
Jan 2025 130d
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
K240948 · QJP Catheter, Percutaneous,... · Neurology
Jun 2024 59d
Zoom 6F Insert Catheters
K233975 · DQO Catheter, Intravascular,... · Cardiovascular
Apr 2024 109d
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
K231168 · QJP Catheter, Percutaneous,... · Neurology
May 2023 27d
Imperative Care Radial 088 Access System
K220807 · QJP Catheter, Percutaneous,... · Neurology
May 2022 60d
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
K212224 · QJP Catheter, Percutaneous,... · Neurology
Sep 2021 66d
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
K211476 · NRY Catheter, Thrombus Retriever · Neurology
Jun 2021 27d
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
K210996 · NRY Catheter, Thrombus Retriever · Neurology
Apr 2021 21d
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
K203764 · QJP Catheter, Percutaneous,... · Neurology
Mar 2021 70d
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
K202182 · NRY Catheter, Thrombus Retriever · Neurology
Sep 2020 29d
0.071? ID MantaRay Reperfusion Catheter, 0.055? ID MantaRay Reperfusion Catheter, 0.045? ID MantaRay Reperfusion Catheter, 0.035? ID MantaRay Reperfusion Catheter
K183043 · NRY Catheter, Thrombus Retriever · Neurology
Apr 2019 166d
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 Length
K180169 · DQY Catheter, Percutaneous · Neurology
Aug 2018 198d
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