T Series Vessel Tips
by Akcess Medical Products, Inc.
510(k) K893438
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893438 | Date8 Jun 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FKW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The T Series Vessel Tips are classified as Tip, Vessel medical devices under FDA Product Code FKW, designed for use in portal vein procedures. These devices are intended for vascular access or embolization applications within the gastrointestinal and urological specialties, as reviewed by the Gastroenterology and Urology Advisory Committee. Their design aligns with Class II regulatory standards, ensuring compliance with FDA requirements for substantially equivalent performance to predicate devices.
Supplied as single-use disposable devices, the T Series Vessel Tips are intended for sterile use in controlled clinical settings. They are available in multiple sizes (13–18, as referenced in comparable submissions) and must be stored according to manufacturer guidelines to maintain sterility and functionality. The device holds an FDA 510(k) clearance (K893438) under the Traditional pathway, with no third-party certification noted. Compliance with FDA regulation 876.5540 governs their classification and use.
Other devices from Akcess Medical Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the T Series Vessel Tips designed for?
The T Series Vessel Tips are specifically designed for vascular access or embolization procedures within the portal vein system. These applications are commonly used in gastrointestinal and urological specialties to manage blood flow or block vessels as needed for clinical interventions.
Are the T Series Vessel Tips reusable or single-use?
The T Series Vessel Tips are supplied as single-use disposable devices. This design ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for medical device usage in clinical settings.
What sizes are available for the T Series Vessel Tips?
The T Series Vessel Tips come in multiple sizes, ranging from 13 to 18 as referenced in regulatory submissions. These sizes accommodate various clinical needs for portal vein procedures, ensuring compatibility with different patient anatomies and procedural requirements.
How should the T Series Vessel Tips be stored?
To maintain sterility and functionality, the T Series Vessel Tips must be stored according to the manufacturer’s guidelines. Proper storage conditions are critical to preserving the device’s integrity and ensuring safe use in clinical environments.
What regulatory pathway does the T Series Vessel Tips follow?
The T Series Vessel Tips hold an FDA 510(k) clearance under the Traditional pathway, with clearance number K893438. This pathway confirms that the device is substantially equivalent to a predicate device and complies with FDA regulations for Class II medical devices under product code FKW.