# K212199: ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 3, 2021 after 112 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: 4 generations back to K052232 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100569: Merit Embolectomy Catheter Model ASAP100, Merit Medical Systems, Inc. (2011) Summary page 4.
- K132155: Merit ASAPLP Aspiration Catheter, Merit Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
The Merit ASAP® Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature. The Merit ASAPLP™ Aspiration Catheter is intended 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/K212199
Methodology: https://510kreport.com/methodology