Identity
- Trade Name
- DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT FDA PMA
- Generic Name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL FDA PMA
Identifiers
- PMA Number
- P860064 FDA PMA
- FDA Product Code
- LNY FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General Hospital FDA PMA
- FDA Decision
- APWD FDA PMA
The Davol Externalized Epidural Catheter is a Catheter, Percutaneous, Long Term, Intraspinal, designed for prolonged epidural access. It facilitates continuous administration of medications or fluids into the epidural space while minimizing infection risk through its antimicrobial cuff technology.
This device is supplied sterile and intended for single-use in hospital settings, adhering to FDA Premarket Approval (PMA P860064). It includes a repair kit and is classified under FDA device class III (product code LNY). Proper storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the primary purpose of the Davol Externalized Epidural Catheter and how does it reduce infection risk during use?
The Davol Externalized Epidural Catheter is designed for prolonged epidural access, allowing continuous administration of medications or fluids into the epidural space. Its antimicrobial cuff technology helps minimize infection risk by providing a barrier against microbial migration, which is critical for long-term use in hospital settings.
Is this catheter intended for reuse or single-use, and what does that mean for hospital workflows?
This catheter is explicitly intended for **single-use only**, meaning it is supplied sterile and should not be reused after a single patient procedure. This design choice aligns with best practices for infection control and ensures sterility, simplifying hospital workflows by eliminating the need for reprocessing or sterilization between uses.
What accessories are included with the Davol Externalized Epidural Catheter, and how do they support its functionality?
The catheter comes with a **repair kit**, which provides tools or components to address potential in-use issues (e.g., minor disconnections or leaks) without compromising sterility. This ensures continued functionality while adhering to single-use guidelines, though repairs should follow manufacturer instructions to maintain safety.
How should the Davol Externalized Epidural Catheter be stored to preserve its sterility and performance?
Storage must follow the manufacturer’s guidelines to maintain both sterility and functionality. Since it is supplied sterile and single-use, it should be kept in its original packaging until immediately before use, protected from contamination, moisture, and physical damage. Avoid exposure to extreme temperatures or direct sunlight, as these could degrade the antimicrobial cuff or catheter integrity.
What regulatory pathway does this device follow, and what does that mean for healthcare providers?
The Davol Externalized Epidural Catheter follows the **FDA Premarket Approval (PMA) pathway**, indicated by PMA number **P860064**. This means it underwent rigorous review by the FDA to ensure safety and effectiveness for its intended use as a long-term intraspinal catheter. For healthcare providers, this approval signifies compliance with stringent regulatory standards, though it does not imply any clinical indication—only that the device meets FDA requirements for market authorization.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P860064 | Class III | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA PMA P860064 24 fields · synced Sep 18, 2026