FDA 510(k) Applications Submitted by Imperative Care Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180169 |
01/22/2018 |
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, |
Imperative Care Inc. |
| K202182 |
08/04/2020 |
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing |
Imperative Care Inc. |
| K183043 |
11/02/2018 |
0.071ö ID MantaRay Reperfusion Catheter, 0.055ö ID MantaRay Reperfusion Catheter, 0.045ö ID MantaRay Reperfusion Catheter, 0.035ö ID MantaRay Reperfusion Catheter |
Imperative Care Inc. |
| K220807 |
03/18/2022 |
Imperative Care Radial 088 Access System |
Imperative Care Inc. |
| K210996 |
04/02/2021 |
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing |
Imperative Care Inc. |
| K212224 |
07/16/2021 |
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform |
Imperative Care Inc. |
| K203764 |
12/23/2020 |
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform |
Imperative Care Inc. |
| K231168 |
04/25/2023 |
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support |
Imperative Care Inc. |
| K211476 |
05/12/2021 |
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing |
Imperative Care Inc. |
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