# K960574: Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Aug 5, 1996 after 175 days
- Product code: FHO (Pneumoperitoneum Needle)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934428 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934428: Argyle Turkel Safety Pneumothorax Procedure Tray, Sherwood Medical Co. (1993) Summary page 1.
- (no number) Argyle Trocar Catheters & Trocar Catheter Kits: named in the summary without a submission number

## Indications for use
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.

Source page: https://510kreport.com/device/K960574
Methodology: https://510kreport.com/methodology