Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233988 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
- Models / Variants
- Cerenovus Large Bore Catheter FDA 510(k)Cerenovus Aspiration Tubing Set FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset. The device is designed to restore blood flow by removing thrombus in patients experiencing ischemic stroke.
The device is supplied as a catheter with an aspiration tubing set and is intended for single use. It is classified under product code NRY and has received FDA 510(k) clearance with decision code SESE. The device is regulated under 870.1250 and is manufactured by Cerenovus, Inc.
Frequently asked questions
What is the Cerenovus Large Bore Catheter used for?
The Cerenovus Large Bore Catheter, with the Aspiration Tubing Set and compatible pump, is designed to restore blood flow by removing thrombus in patients experiencing acute ischemic stroke due to intracranial large vessel occlusive disease within 8 hours of symptom onset.
How is the Cerenovus Large Bore Catheter supplied?
The device is supplied as a catheter with an aspiration tubing set and is intended for single use only. It comes ready for use with a compatible aspiration pump to perform thrombus removal procedures.
What is the regulatory status of this device?
The Cerenovus Large Bore Catheter has received FDA 510(k) clearance with decision code SESE, classified under product code NRY, and is regulated under 870.1250. It is manufactured by Cerenovus, Inc.
Is the Cerenovus Large Bore Catheter reusable?
No, the device is intended for single use only. After use, it should be disposed of according to medical waste disposal protocols to ensure patient safety and prevent cross-contamination.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set by ..., DeviceMD - CERENOVUS Large Bore Catheter, CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233988 | Class II | Active |
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Manufacturer
- Manufacturer
- Cerenovus, Inc.
Sources (1)
- FDA 510(k) K233988 24 fields · synced Oct 6, 2026