Accu-Chek FlexLink Plus Infusion Set
by Roche Diagnostics GmbH Germany 510(k)
510(k) K143446 Product code FPA
Overview
The Accu-Chek FlexLink Plus Infusion Set is a subcutaneous infusion device designed for the administration of insulin via an insulin pump. Classified under the regulatory category for intravascular devices, it is intended for continuous insulin delivery through a flexible cannula inserted under the skin. This set is engineered to connect directly to insulin pumps, ensuring precise and steady insulin infusion for diabetes management. Its construction facilitates ease of use while maintaining reliability for long-term therapeutic applications.
The infusion set is supplied sterile and intended for single-use only, adhering to standard aseptic handling protocols. It is compatible with insulin pumps and must be inserted by the user or under medical supervision in a clinical or home setting. The device is regulated under 21 CFR 880.5440 and holds FDA 510(k) clearance (K143446) as substantially equivalent to a predicate device. Storage instructions specify protection from moisture and extreme temperatures, ensuring optimal performance and sterility until use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143446 | Date13 Aug 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Roche Diagnostics GmbH
Questions
What is the Accu-Chek FlexLink Plus infusion set used for?
The Accu-Chek FlexLink Plus infusion set is designed for continuous subcutaneous insulin delivery in diabetes management. It connects directly to insulin pumps to provide steady, precise insulin infusion through a flexible cannula inserted under the skin. This setup is ideal for users requiring long-term, automated insulin therapy to maintain stable blood glucose levels.
Is the Accu-Chek FlexLink Plus infusion set sterile and single-use?
Yes, the Accu-Chek FlexLink Plus infusion set is supplied sterile and intended for single-use only. This ensures aseptic handling and reduces the risk of infection or contamination, adhering to standard medical device protocols for patient safety.
How should the Accu-Chek FlexLink Plus infusion set be stored?
The infusion set must be stored in a dry environment, protected from moisture and extreme temperatures. Proper storage conditions help maintain its sterility and performance until use. Always follow the manufacturer’s guidelines to ensure the device remains effective for its intended application.
Can this infusion set be reused?
No, the Accu-Chek FlexLink Plus infusion set is explicitly designed for single-use only. Reusing it could compromise sterility, increase infection risks, and reduce the accuracy of insulin delivery. Each set is engineered for one-time use to ensure reliability and patient safety.
What regulatory clearance does the Accu-Chek FlexLink Plus infusion set hold?
The Accu-Chek FlexLink Plus infusion set holds FDA 510(k) clearance (K143446) as substantially equivalent to a predicate device. This clearance confirms it meets regulatory standards for safety and effectiveness as an intravascular device under 21 CFR 880.5440. Always refer to official regulatory documentation for detailed compliance information.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K143446