# K100569: Merit Embolectomy Catheter Model ASAP100

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 11, 2011 after 375 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- 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: 2 generations back to K052232 (2005). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K063371: Pronto V3 Extraction Catheter, Model 5003, Vascular Solutions, Inc. (2006) Summary page 5.

## Most influential descendants
- K132155: Merit ASAPLP Aspiration Catheter (2013), 1 descendant of its own
- K212199: ASAP Aspiration Catheter, ASAPLP Aspiration Catheter (2021), 0 descendants of its own

## Indications for use
The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. - Not for use in cerebral vasculature.

Source page: https://510kreport.com/device/K100569
Methodology: https://510kreport.com/methodology