Interlink Blunt Cannula, Modification
510(k) K911868
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911868 | Date24 Jun 1991 | 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- Withdrawn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
- Full name
- Interlink(Tm) Blunt Cannula, Modification
- 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
Overview
AI-generated summary, 1 Oct 2026
The Interlink Blunt Cannula, Modification is a Set, Administration, Intravascular device (product code FPA), designed for secure, atraumatic insertion into intravenous access ports or similar vascular access systems. Its blunt tip reduces the risk of vessel perforation or damage during cannulation, facilitating reliable fluid administration or medication delivery. Constructed for compatibility with standard intravenous access systems, it ensures stable connection while minimizing trauma to the patient’s vasculature.
This device is supplied as a single-use item, intended for sterile use in hospital or clinical settings where intravenous access is required. It is classified under FDA 510(k) clearance (K911868) and falls under Class II regulatory controls, with no additional third-party certification noted. Storage and handling must adhere to sterile medical device protocols, and its design aligns with intravenous administration systems as defined by regulatory product codes. No MRI safety or reusable specifications are indicated in the submission data.
Other devices from Baxter Healthcare Corp
Questions
AI-generated answers, 1 Oct 2026
What is the Interlink Blunt Cannula, Modification used for?
The Interlink Blunt Cannula, Modification is designed specifically for secure, atraumatic insertion into intravenous access ports or similar vascular access systems. Its blunt tip minimizes the risk of vessel perforation or trauma during cannulation, making it ideal for reliable fluid administration or medication delivery in clinical settings.
Is the Interlink Blunt Cannula, Modification intended for single-use or reuse?
This device is explicitly intended for single-use only. It is supplied sterile and must be discarded after one use to maintain patient safety and sterility standards, as outlined in its design and regulatory submission.
How should the Interlink Blunt Cannula, Modification be stored?
The device must be stored and handled according to sterile medical device protocols. Since it is single-use and sterile upon packaging, it should remain in its original, unopened packaging until immediate clinical use to prevent contamination.
What regulatory pathway does the Interlink Blunt Cannula, Modification follow?
The Interlink Blunt Cannula, Modification is classified under FDA 510(k) clearance (K911868) and falls under Class II regulatory controls. It was determined to be substantially equivalent to a legally marketed device through a traditional review process by the FDA’s General Hospital Orthopaedic Devices (HO) advisory committee.
Can this device be used with standard intravenous access systems?
Yes, the Interlink Blunt Cannula, Modification is constructed for compatibility with standard intravenous access systems. Its design ensures a stable connection while minimizing trauma to the patient’s vasculature, making it suitable for integration with existing clinical workflows.