DC-4 Shunt Infusion T
by Akcess Medical Products, Inc.
510(k) K891754
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK891754 | Date7 Apr 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The DC-4 Shunt Infusion T is a connector device used in medical applications. It is classified as a Connector, Blood Tubing, Infusion T and is intended for use in gastroenterology and urology procedures.
The device is supplied by Akcess Medical Products, Inc. and has FDA 510(k) clearance with product code FKB. It is a Class II medical device and is regulated under number 876.5820. The device is available in the DC-4 model and is not specified as single-use or reusable in the provided data.
Other devices from Akcess Medical Products, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the DC-4 Shunt Infusion T used for?
The DC-4 Shunt Infusion T is a connector device specifically designed for use in gastroenterology and urology procedures. It functions as a blood tubing infusion T connector to facilitate medical applications in these specialties.
How is the DC-4 Shunt Infusion T supplied?
The DC-4 Shunt Infusion T is supplied by Akcess Medical Products, Inc. The device is available in the DC-4 model, though the provided data does not specify whether it is single-use or reusable.
What is the regulatory status of the DC-4 Shunt Infusion T?
The DC-4 Shunt Infusion T has FDA 510(k) clearance with product code FKB. It is classified as a Class II medical device regulated under number 876.5820. The device received traditional clearance on April 7, 1989.
Are there different sizes or models of the DC-4 Shunt Infusion T available?
The provided data indicates the DC-4 Shunt Infusion T is available in the DC-4 model. No other sizes or models are mentioned in the device specifications.