PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151985 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)
This device is a Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, designed for central venous access. It incorporates ethanol-resistant materials to facilitate prolonged exposure to intraluminal solutions containing up to 70% ethanol, enabling intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The catheter is available in configurations suitable for short- and long-term peripheral access to the central venous system.
The PowerPICC EtOH Catheter and PowerPICC SOLO² EtOH Catheter are supplied sterile for single-use. They are classified as Class II devices under FDA regulations (880.5970) and were granted FDA 510K clearance (K151985) as substantially equivalent to the predicate device. The SOLO² variant includes a proximal valve for clamp-free infusion, with trimmable and multi-lumen options. Storage and handling follow standard sterile medical device 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™2 Catheter, I.R. | BD, PowerPICC SOLO™ Catheter - BD, PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter, PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151985 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K151985 24 fields · synced Oct 6, 2026