Hemovac Chest Drainage Solution
510(k) K800861
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800861 | Date2 May 1980 | 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- Withdrawn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
- Full name
- Snyder Hemovac Chest Drainage Solution
- 510(k) Number
- FDA Product Code
- KDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Hemovac Chest Drainage Solution is a chest drainage device designed to evacuate air, blood, or serous fluid from the pleural space or thoracic cavity. It employs a vacuum-assisted system with a disposable, single-use plastic tube and connector assembly to promote drainage and reduce post-surgical complications such as pneumothorax or hemothorax.
This device is supplied sterile, intended for single-use only, and features a 19 French outer diameter (O.D.) drain with a 4-inch long trocar and connector, paired with a 400 ml capacity evacuator. It is manufactured from polyvinyl chloride (PVC) and must be disposed of after initial use. The solution is authorized under FDA 510(k) clearance (K800861) and falls under the KDQ product code for chest drainage systems.
Other devices from Snyder Laboratories, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of fluids can the Snyder Hemovac Chest Drainage Solution remove from the pleural space or thoracic cavity?
The Snyder Hemovac Chest Drainage Solution is specifically designed to evacuate air, blood, or serous fluid from the pleural space or thoracic cavity. This makes it suitable for post-surgical drainage scenarios where these fluids may accumulate, such as after thoracic or cardiac procedures.
Is the Snyder Hemovac Chest Drainage Solution reusable, or is it intended for single-use only?
The Snyder Hemovac Chest Drainage Solution is explicitly intended for single-use only. The device is supplied sterile and must be disposed of after its initial use to maintain patient safety and sterility standards.
What is the capacity of the evacuator component in the Snyder Hemovac Chest Drainage Solution, and what size drain tube does it include?
The evacuator component of the Snyder Hemovac Chest Drainage Solution has a capacity of 400 ml, and it includes a 19 French outer diameter (O.D.) drain tube paired with a 4-inch long trocar and connector.
How is the Snyder Hemovac Chest Drainage Solution supplied, and what materials is it made from?
The Snyder Hemovac Chest Drainage Solution is supplied sterile and consists of a disposable, single-use plastic tube and connector assembly. The device is manufactured from polyvinyl chloride (PVC), ensuring durability while maintaining compatibility with medical-grade standards.
What regulatory pathway was followed for FDA clearance of the Snyder Hemovac Chest Drainage Solution, and what product code does it fall under?
The Snyder Hemovac Chest Drainage Solution received FDA clearance through a 510(k) submission (K800861) under the Traditional clearance type, with a decision of Substantially Equivalent (SESE). It falls under the KDQ product code, which categorizes it as a chest drainage system.