# K102925: Nexgen Expandable Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nexgen Medical Systems, Inc.
- Decided: Nov 10, 2011 after 402 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
Longest line of descent: 3 generations back to K890766 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070865: Expanding Vascular Sheath, Applied Medical (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K961886: Drager Gemina Wall-Mounted Workplace, Alm Surgical Equipment, Inc. (1996). Our reading of the summary gave K961886, FDA’s number for Drager Gemina Wall-Mounted Workplace (Alm Surgical Equipment, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Applied Medical Expandable Vascular Sheath”. Kept off the family tree. Summary page 2.

## Indications for use
The NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the peripheral vascular systemn and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K102925
Methodology: https://510kreport.com/methodology