Pleur-Evac(R) Adult/Pedi Dual Coll Chest Drain Sys
510(k) K924337
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924337 | Date28 Jul 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCX
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pleur-Evac Adult/Pediatric Dual Collar Chest Drain System is a medical device classified as a chest drainage system designed for the evacuation of air, blood, or other fluids from the pleural space. It facilitates the restoration of negative intrapleural pressure in patients with conditions such as pneumothorax, hemothorax, or post-surgical drainage requirements. The dual-collar design accommodates varying patient anatomies, ensuring secure placement and effective drainage.
This system is supplied as a sterile, single-use device intended for use in hospital settings, including intensive care, thoracic surgery, and trauma care. It is compatible with standard wall suction sources and includes components such as a collection chamber, drainage tubing, and a dual-collar connector to adapt to adult or pediatric patients. The device adheres to FDA 510(k) clearance under the General Hospital advisory committee classification (K924337) and is regulated under the GCX product code. Storage requires protection from contamination and extreme temperatures.
Other devices from Deknatel, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Pleur-Evac Dual-Collar Chest Drain System used for?
The Pleur-Evac Dual-Collar Chest Drain System is designed to evacuate air, blood, or other fluids from the pleural space, helping restore negative intrapleural pressure. It is specifically indicated for patients with conditions such as pneumothorax, hemothorax, or those requiring post-surgical drainage. The dual-collar design adapts to both adult and pediatric anatomies, ensuring a secure fit and effective drainage.
Is the Pleur-Evac Dual-Collar Chest Drain System single-use or reusable?
This device is supplied as a sterile, single-use system. It is intended for one-time use in clinical settings to prevent contamination and ensure patient safety. Reuse is not recommended as it may compromise sterility and device integrity.
How is the Pleur-Evac Dual-Collar Chest Drain System supplied?
The system is supplied as a complete, sterile package containing a collection chamber, drainage tubing, and a dual-collar connector. It is designed for immediate use in hospital environments such as intensive care, thoracic surgery, or trauma care. The components are pre-assembled to simplify setup and reduce the risk of contamination.
What storage conditions are required for the Pleur-Evac Dual-Collar Chest Drain System?
The device must be stored in a clean, dry environment protected from contamination and extreme temperatures. Proper storage ensures the integrity of the sterile packaging and the functionality of the components. Avoid exposure to direct sunlight, moisture, or temperatures outside the manufacturer’s recommended range.
Can the Pleur-Evac Dual-Collar Chest Drain System be used with standard wall suction?
Yes, this system is compatible with standard wall suction sources. The design allows for efficient evacuation of fluids and air from the pleural space, making it suitable for integration into existing hospital suction setups. Always follow manufacturer guidelines for proper connection and operation.