Pleur-Evac A-8002--Adult/Pediatric Dual Collection
510(k) K892915
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892915 | Date21 Jun 1989 | 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- Withdrawn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
- KDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Pleur-Evac A-8002 Adult/Pediatric Dual Collection is a chest drainage system designed for the evacuation of pleural fluid or air from the thoracic cavity. It features a dual-chamber configuration to simultaneously manage drainage from two catheter sites, facilitating effective management of conditions such as pneumothorax, pleural effusion, or postoperative fluid accumulation. The system incorporates safety mechanisms to ensure controlled fluid collection and prevent contamination or air embolism. Its design accommodates both adult and pediatric patients, offering versatility in clinical settings.
This device is supplied as a single-use, sterile system and is intended for use in hospital environments where chest drainage is required. It operates under wet-seal principles, ensuring reliable suction control while minimizing the need for manual adjustments. The Pleur-Evac A-8002 complies with FDA 510(k) clearance (K892915) under the product code KDQ, with a decision date of June 21, 1989. Storage instructions and MRI safety are not specified in the available data, but standard sterile medical device handling applies.