Infusion Set for PowerPICC Solo 2 Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102405 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an infusion set designed for use with the PowerPICC Solo 2 catheter, classified under the product code FPA. It serves as a conduit for intravenous fluid administration, blood sampling, and central venous pressure monitoring, while also facilitating power injection and saline maintenance. The set is engineered to open the catheter’s proximal valve upon connection, ensuring uninterrupted fluid flow. Its primary function is to interface between an external IV administration set and the indwelling catheter, enabling reliable vascular access in clinical settings.
The infusion set is intended for single-use only, with a maximum recommended duration of 96 hours. It is supplied sterile and intended for use in hospital or clinical environments by healthcare professionals. No specific MRI safety information is provided, and the device is not reusable. Storage and handling must comply with standard sterile medical device protocols. Authorisation for this device includes FDA 510(k) clearance under the K102405 submission, classified as substantially equivalent under the General Hospital advisory committee.
Frequently asked questions
What is the PowerPICC Solo 2 infusion set designed for?
The infusion set is specifically engineered to interface between an external IV administration system and the PowerPICC Solo 2 catheter. It provides a conduit for intravenous fluid administration, blood sampling, and central venous pressure monitoring. Additionally, it supports power injection and saline maintenance, ensuring seamless fluid flow by automatically opening the catheter’s proximal valve upon connection.
How is the infusion set supplied and what are its sterility and reuse guidelines?
The infusion set is supplied sterile and intended exclusively for single-use in hospital or clinical environments by healthcare professionals. It is not designed for reuse, and adherence to standard sterile medical device protocols is required during storage and handling. The maximum recommended duration of use is 96 hours.
Is MRI safety information provided for this infusion set?
No specific MRI safety information is included for this infusion set. Clinicians should verify compatibility with their MRI protocols before use, as the device’s materials or components may not be explicitly tested or approved for MRI environments.
What regulatory clearance does this infusion set hold?
The infusion set holds FDA 510(k) clearance under submission K102405, classified as substantially equivalent under the General Hospital advisory committee. This clearance indicates that the device meets regulatory standards for safety and effectiveness as determined by the FDA.
What storage and handling precautions should be taken for this infusion set?
The infusion set must be stored and handled according to standard sterile medical device protocols to maintain its integrity and sterility. Since it is single-use, it should be kept in its original packaging until immediately before use, and any exposed components should be discarded to prevent contamination.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PowerPICC SOLO™ 2 Catheter, Nursing | BD, Infusion Set for Powerpicc Solo 2 Catheter, PowerPICC SOLO™2 Catheter, I.R. | BD, K102405 - INFUSION SET FOR POWERPICC SOLO 2 CATHETER | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102405 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K102405 24 fields · synced Oct 1, 2026