Arterial Canalization Device
FDA 510(k)Class II (US FDA 510(k))
by Alimed, Inc.
Identifiers
- 510(k) Number
- K820516 FDA 510(k)
- FDA Product Code
- DQY 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)
An arterial canalization device is a cardiovascular device used to establish access to an artery for medical procedures. It is designed to facilitate the insertion of catheters or other instruments into the arterial system.
This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is not MRI conditional or labeled for single-use. The device received traditional 510(k) clearance (K820516) and is classified under product code DQY with cardiovascular advisory committee review.
Frequently asked questions
What is the arterial canalization device used for?
The arterial canalization device is used to establish access to an artery for medical procedures, specifically to facilitate the insertion of catheters or other instruments into the arterial system during cardiovascular interventions.
Is the arterial canalization device sterile when supplied?
The device is supplied non-sterile and requires the user to perform appropriate cleaning and sterilization before each use, as it is intended for reusable application following proper reprocessing.
Can the arterial canalization device be reused?
Yes, the device is intended for reusable use after appropriate cleaning and sterilization by the user; it is not labeled for single-use and must be reprocessed according to validated methods prior to each procedure.
What regulatory pathway was used for the arterial canalization device?
The device received traditional 510(k) clearance under number K820516, demonstrating substantial equivalence to a predicate device, and is classified under product code DQY with cardiovascular advisory committee review.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K820516 | Class II | Active |
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Manufacturer
- Manufacturer
- Alimed, Inc.
Sources (1)
- FDA 510(k) K820516 24 fields · synced Sep 23, 2026