# K992940: Lemaitre Balloon Catheter with Irrigation

- Pathway: 510(k) (Traditional)
- Applicant: Vascutech, Inc.
- Decided: Feb 22, 2000 after 175 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041517: Infusioncath (2004), 3 descendants of its own
- K052738: Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 (2005), 1 descendant of its own
- K073400: Varicath Peripheral Infusion Catheter (2007), 0 descendants of its own
- K052844: Kavs - Catheter, Models 1107100 & 1107060 (2006), 0 descendants of its own

## Indications for use
The LeMaitre Balloon Catheter with Irrigation is indicated for the extraction of emboli and thrombi from the peripheral arterial system and also may be used for infusion of fluids.

Source page: https://510kreport.com/device/K992940
Methodology: https://510kreport.com/methodology