0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter
FDA 510(k) K183043 · Imperative Care, Inc.
Submission
- Device name
- 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter
- Applicant
- Imperative Care, Inc.
Campbell, CA, US - Received
- November 2, 2018
- Decision date
- April 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| K261176 | Zoom 4S CatheterQJP · Traditional | 08/28/2026SE |
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| K244061 | X-Wire GuidewireMOF · Traditional | 08/26/2025SE |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRY · Traditional | 05/28/2025SE |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy SystemQEW · Special | 05/14/2025SE |
| K242672 | Zoom SystemNRY · Traditional | 01/14/2025SE |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Traditional | 06/06/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | 04/02/2024SE |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Special | 05/22/2023SE |
Questions and answers
When was 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter cleared by the FDA?
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) received a 510(k) decision of Substantially Equivalent on April 17, 2019, 166 days after the submission was received.
What is the product code of K183043?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.