# K971851: Interpleural Anesthesia Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Medical, Inc.
- Decided: Jan 22, 1998 after 247 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- 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) Mills Filtered Mediastinal Sump: named in the summary without a submission number
- (no number) Interpleural Anesthesia Kit with Polyurethane Catheter: named in the summary without a submission number

## Indications for use
Typical applications include: For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.

Source page: https://510kreport.com/device/K971851
Methodology: https://510kreport.com/methodology