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PowerPICC Solo

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072230

by C. R. Bard, Inc.

Identifiers

510(k) Number
K072230 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PowerPICC Solo is a Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, designed for peripheral insertion into the central venous system. It features a proximal valve mechanism to facilitate clamp-free infusion, accommodating high-pressure injections up to 300 psi and flow rates of 5 mL per second. Available in single, double, and triple lumen configurations, it supports short- and long-term vascular access for therapeutic and diagnostic procedures.

This device is supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance as substantially equivalent to prior devices. The PowerPICC Solo is compatible with MRI environments when non-ferromagnetic materials are confirmed, though specific MRI safety considerations should be verified per facility protocols. Storage requires protection from extreme temperatures and moisture, adhering to standard sterile medical device handling guidelines.

Frequently asked questions

What types of medical procedures or patients is the PowerPICC Solo designed to support with its lumen configurations?

The PowerPICC Solo is designed for short- and long-term vascular access (over 30 days) in patients requiring therapeutic or diagnostic procedures. Its single, double, and triple lumen configurations allow for simultaneous administration of multiple medications, fluids, or monitoring (e.g., blood draws, pressure measurements) through a single peripheral insertion site into the central venous system. This is particularly useful in general hospital settings for patients needing reliable, high-flow access without frequent catheter replacements.

How does the proximal valve mechanism in the PowerPICC Solo improve infusion reliability compared to traditional catheters?

The proximal valve mechanism in the PowerPICC Solo eliminates the need for clamps during infusion, reducing the risk of accidental disconnections or leaks. It accommodates high-pressure injections up to 300 psi and flow rates of 5 mL per second, making it ideal for procedures requiring rapid or forceful fluid delivery—such as contrast media injections or emergency resuscitation—while maintaining secure, clamp-free operation.

Is the PowerPICC Solo safe to use in MRI environments, and what precautions should be taken?

The PowerPICC Solo is compatible with MRI environments *only if* the facility confirms the absence of ferromagnetic materials in the specific model being used. While the device itself may not contain ferromagnetic components, MRI safety protocols must be verified per facility guidelines to avoid risks like heating or displacement during imaging. Always consult your MRI technician or radiology department before use.

How should the PowerPICC Solo be stored to maintain sterility and functionality before use?

The PowerPICC Solo is supplied sterile and must be stored in its original packaging to protect it from extreme temperatures, moisture, and contamination. Follow standard sterile medical device handling guidelines, including keeping it in a clean, dry environment away from direct sunlight or sources of heat. Avoid exposing the packaging to liquids or sharp objects that could compromise sterility.

Can the PowerPICC Solo be reused, or is it intended for single-use only?

The PowerPICC Solo is intended for single-use only and should not be reused or reprocessed. Single-use design ensures patient safety by eliminating risks associated with contamination or degradation of materials after one use. Discard after use in accordance with local medical waste disposal protocols.

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™ Catheter - BD, BARD POWERPICC SOLO2 MANUAL Pdf Download | ManualsLib, BARD POWERPICC SOLO 2 PATIENT MANUAL Pdf Download, POWERPICC SOLO by C.R. BARD, INC. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K072230 24 fields · synced Sep 18, 2026