# K970857: Argyle Aqua-Seal All Purpose Autotransfusion Chest Drainage Unit and Optional Argyle Aqua-Seal Evacuating Autotransfusio

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Nov 5, 1997 after 240 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Atrium Self-Sealing ATS bag: named in the summary without a submission number
- (no number) Argyle® Aqua-Seal® Continuous Autotransfusion Chest Drainage Unit: named in the summary without a submission number
- (no number) Atrium Multipurpose Chest Drainage Unit: named in the summary without a submission number

## Indications for use
1. Evacuation and collection of blood and/or air from the mediastinal and pleural cavity in post-operative and trauma situations. 2. Collection and reinfusion of autologous blood from the mediastinal and pleural cavity in post-operative and trauma situations. 3. Prevention of fluid and/or air re-accumulation in the mediastinal and pleural cavity. 4. Facilitation of complete lung re-expansion and restoration of normal breathing dynamics.

Source page: https://510kreport.com/device/K970857
Methodology: https://510kreport.com/methodology