Landmark Midline Catheter
by Menlo Care, Inc. 510(k)
Active
510(k) K944968
Overview
The Landmark Midline Catheter is a catheter, intravascular, therapeutic, short-term (less than 30 days) designed for venous access in clinical settings. It provides a reliable pathway for administering fluids, medications, or drawing blood samples, with a focus on mid-line insertion to avoid central venous access risks. Constructed for short-term use, it is intended for patients requiring prolonged peripheral access beyond standard peripheral catheters but not necessitating central venous catheterization. The device is classified under the FOZ product code and is intended for general hospital use.
This catheter is supplied as a sterile, single-use device, ensuring patient safety and infection control. It is intended for use in hospital settings where venous access is required for short-term therapeutic or diagnostic procedures. The device adheres to FDA 510(k) clearance (K944968) under the Traditional review pathway, with a decision date of March 29, 1995, and is classified as substantially equivalent to predicate devices. No additional regulatory markings or MRI safety classifications are specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944968 | Date29 Mar 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Menlo Care, Inc.
Questions
What is the Landmark Midline Catheter designed for?
The Landmark Midline Catheter is specifically designed for short-term venous access (up to 30 days) in clinical settings where patients require prolonged peripheral access beyond standard catheters but do not need central venous catheterization. It provides a stable pathway for administering fluids, medications, or drawing blood samples, minimizing risks associated with central line insertion.
Is the Landmark Midline Catheter sterile and single-use?
Yes, the Landmark Midline Catheter is supplied as a sterile, single-use device. This ensures patient safety and reduces the risk of infection, as it is intended for one-time use only in controlled hospital environments.
What are the key differences between this catheter and standard peripheral catheters?
Unlike standard peripheral catheters, the Landmark Midline Catheter is inserted into a mid-line vein (typically the basilic or cephalic vein in the arm), allowing for longer-term use (up to 30 days) without the risks associated with central venous access. This makes it ideal for patients needing extended venous access for therapeutic or diagnostic procedures.
How is the Landmark Midline Catheter classified and regulated?
The Landmark Midline Catheter is classified under the FOZ product code for general hospital use and has received FDA 510(k) clearance (K944968) under the Traditional review pathway. It is deemed substantially equivalent to predicate devices, meaning it meets the same performance standards as existing, legally marketed catheters of this type.
Where is this catheter intended for use?
This catheter is intended exclusively for use in hospital settings where venous access is required for short-term therapeutic or diagnostic procedures. Its design and sterility make it suitable for controlled clinical environments where infection control is critical.