# K993191: TFX Medical Introducer Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Tfx Medical, Inc.
- Decided: Mar 24, 2000 after 183 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices 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) Burron Tear-Away Sheath Introducers: named in the summary without a submission number
- (no number) Daig Corporation introducer Set: named in the summary without a submission number

## Most influential descendants
- K022513: Medcomp Vascu-Sheath Introducer Set (2002), 16 descendants of its own
- K053092: Medcomp Vascu-Sheath II (2006), 14 descendants of its own
- K090394: Valved Tearway Introducer (2009), 12 descendants of its own
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), 4 descendants of its own
- K160437: PleurX Peritoneal Catheter System (2016), 2 descendants of its own

## Indications for use
The TFX Medical Introducer Assembly will be used to provide access to the venous system for device entry, when used in conjunction with additional percutaneous entry devices.

Source page: https://510kreport.com/device/K993191
Methodology: https://510kreport.com/methodology