5 FR Dual Lumen Piper PICC
510(k) K181904
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181904 | Date25 Sep 2018 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- LJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5970
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The 5 Fr Dual Lumen Piper PICC is a percutaneous, implanted, long-term intravascular catheter designed for central venous access. It features two lumens for simultaneous administration of intravenous therapies, blood sampling, or infusion of contrast media, enabling reliable vascular access over extended periods.
This device is intended for single-use in hospital settings and is classified under 21 CFR 880.5970 as a Class II medical product. Supplied sterile and non-reusable, it adheres to FDA 510(k) clearance (K181904) and is intended for general hospital use. Compatibility with MRI is not specified, and proper storage follows manufacturer guidelines to maintain sterility.
Other devices from Piper Access, LLC
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the 5 FR Dual Lumen Piper PICC and how does its dual-lumen design benefit patients?
The 5 FR Dual Lumen Piper PICC is designed for long-term central venous access, allowing simultaneous administration of intravenous therapies, blood sampling, or infusion of contrast media. The dual-lumen feature enables healthcare providers to deliver multiple treatments or monitor patients without requiring separate catheters, improving efficiency and reducing patient discomfort.
Is this catheter intended for reuse, or is it meant for single-use only? How should it be stored to maintain sterility?
The 5 FR Dual Lumen Piper PICC is explicitly intended for single-use only in hospital settings. To maintain sterility, it must be stored according to the manufacturer’s guidelines, typically in a sealed, sterile packaging until immediate use. Avoid exposure to moisture, extreme temperatures, or contamination.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for hospitals using it?
The device received FDA clearance through a 510(k) Traditional Review (K181904) under the General Hospital advisory committee classification. This means it was determined to be substantially equivalent to a legally marketed predicate device, confirming its safety and effectiveness for the intended use as a long-term intravascular catheter. Hospitals using it can rely on this clearance as evidence of regulatory compliance.
Are there different sizes or models available for this catheter, and if so, how do they vary?
The device is specifically listed as a 5 French (FR) Dual Lumen catheter, meaning its diameter is standardized at 5 FR. While the data does not specify additional sizes or models beyond this single configuration, the French sizing indicates it is designed for adult central venous access applications. Always verify compatibility with patient anatomy and clinical needs.
Does this catheter have any known compatibility issues with MRI machines, and what precautions should be taken?
The device documentation does not specify MRI compatibility, meaning its safety or performance in an MRI environment has not been explicitly validated. If MRI imaging is required for a patient with this catheter, consult the manufacturer’s guidelines or radiology department to assess risks (e.g., heating, displacement) and follow best practices for non-MRI-compatible devices.