# K100840: Embo Plus Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Hotspur Technologies
- Decided: Jul 12, 2010 after 110 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
Longest line of descent: 1 generation back to K892410 (1989). 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)
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter, Baxter Healthcare Corp (1989) Summary page 1.

## Indications for use
The EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.

Source page: https://510kreport.com/device/K100840
Methodology: https://510kreport.com/methodology