# K050379: CS Medical Adult TTCF Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cs Medical, Inc.
- Decided: Jul 12, 2005 after 147 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- 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) Scoop-I Catheter, Transtracheal Systems, Inc.: named in the summary without a submission number
- (no number) Transtracheal Systems, Inc. TTHF-1000 Mid Section Hose: named in the summary without a submission number

## Indications for use
TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.

Source page: https://510kreport.com/device/K050379
Methodology: https://510kreport.com/methodology