Codman Bactiseal EVD Catheter Set
by Codman & Shurtleff, Inc. 510(k)
Active
510(k) K021653
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021653 | Date29 Jul 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JXG
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5550
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Codman Bactiseal EVD Catheter Set is a Shunt, Central Nervous System and Components, designed for ventricular access in neurosurgical procedures. It features silicone catheters intended to drain cerebrospinal fluid (CSF) and similar fluids from the brain’s ventricles, helping to reduce intracranial pressure. The device is engineered to minimize tissue trauma during insertion, management, and removal due to its soft, flexible construction. Its primary function is to facilitate controlled CSF drainage while maintaining patency and reducing infection risk through its antimicrobial properties.
The set is supplied sterile and intended for single-use in clinical settings such as operating rooms or intensive care units. It adheres to FDA 510(k) clearance under the Neurology advisory committee classification and falls under Device Class II regulatory standards. Compatibility with dimensionally similar drainage systems ensures versatility in neurosurgical applications. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and its design aligns with regulation 882.5550 for external ventricular drainage systems.
Other devices from Codman & Shurtleff, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Codman Bactiseal EVD Catheter Set used for?
The Codman Bactiseal EVD Catheter Set is designed for ventricular access in neurosurgical procedures. It drains cerebrospinal fluid (CSF) from the brain’s ventricles to help reduce intracranial pressure. Its soft, flexible silicone construction minimizes tissue trauma during insertion, management, and removal, while its antimicrobial properties aim to reduce infection risk during CSF drainage.
How is the Codman Bactiseal EVD Catheter Set supplied and prepared for use?
The set is supplied sterile and intended for single-use in clinical environments like operating rooms or intensive care units. It must be handled according to manufacturer guidelines to maintain sterile packaging integrity before use. This ensures safety and compliance with clinical standards for neurosurgical procedures.
Is the Codman Bactiseal EVD Catheter Set reusable or single-use?
The Codman Bactiseal EVD Catheter Set is explicitly designed for single-use only. This design choice aligns with clinical best practices to minimize infection risks and ensure patient safety, as reuse could compromise sterility and integrity.
What storage requirements apply to the Codman Bactiseal EVD Catheter Set?
Storage must adhere strictly to the manufacturer’s guidelines to preserve the sterile packaging of the Codman Bactiseal EVD Catheter Set. This includes protecting it from contamination, moisture, and physical damage, ensuring it remains viable for its intended single-use application in neurosurgical settings.
What regulatory pathway does the Codman Bactiseal EVD Catheter Set follow?
The Codman Bactiseal EVD Catheter Set is cleared under the FDA’s 510(k) pathway, classified as substantially equivalent to a predicate device. It falls under Device Class II regulatory standards and was reviewed by the Neurology Advisory Committee, reflecting its specialized use in neurosurgical drainage systems.