Distal Access Catheter
by Guangzhou Easycess Medical Co., Ltd
510(k) K213065
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213065 | Date31 May 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QJP
- FDA applicant
- Guangzhou Easycess Medical Co.,Ltd
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Distal Access Catheter is a percutaneous neurovascular catheter designed for vascular access procedures. It facilitates the delivery of therapeutic or diagnostic tools to distal neurovascular sites, enabling precise interventions in cerebral vasculature.
This device is supplied as a single-use, non-sterile product and is classified as a Class II medical device under FDA regulations (21 CFR 870.1250). It is intended for use in controlled clinical settings, such as interventional radiology or neurovascular procedures, and requires proper sterilization before use. The catheter is authorized via FDA 510(k) clearance (K213065) and is intended for neurovascular applications as specified in the OpenFDA registry.
Other devices from Guangzhou Easycess Medical Co., Ltd
Questions
AI-generated answers, 19 Sep 2026
What is the primary use of the Distal Access Catheter in clinical settings?
The Distal Access Catheter is specifically designed for percutaneous neurovascular access procedures, enabling the precise delivery of therapeutic or diagnostic tools to distal sites within the cerebral vasculature. This makes it particularly useful in interventional radiology or neurovascular interventions where targeted access to blood vessels in the brain is required.
Is the Distal Access Catheter intended for single-use or reusable applications?
The Distal Access Catheter is supplied as a single-use device, meaning it is not meant to be reused after a single procedure. This aligns with standard practices for neurovascular catheters to ensure patient safety and sterility.
How should the Distal Access Catheter be prepared for use, given it is non-sterile?
Since the Distal Access Catheter is non-sterile, it must undergo proper sterilization before clinical use. This is typically done in a controlled setting, such as a sterile processing department, to ensure it meets regulatory and safety standards for neurovascular procedures.
What regulatory pathway was followed for FDA clearance of this device?
The Distal Access Catheter received FDA clearance through a Traditional 510(k) pathway, with a decision code indicating it was determined to be Substantially Equivalent (SESE) to a predicate device. The clearance was granted under the Cardiovascular (CV) advisory committee and assigned the registration number K213065.
Are there multiple sizes or models available for the Distal Access Catheter?
The provided data lists multiple registration numbers (e.g., 1721676, 3012543881, etc.) under the OpenFDA registry, which may correspond to different product variants or sizes. However, specific dimensions or model distinctions (e.g., length, diameter) are not detailed in the available information. For exact sizing, refer to the manufacturer’s technical documentation or catalog.