# K193197: QuickClear Mechanical Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Atheromed, Inc.
- Decided: Apr 20, 2020 after 152 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: 12 generations back to K003410 (2001). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180939: Indigo Aspiration System - Modified 110 Aspiration Tubing, Penumbra, Inc. (2018) Summary page 5.

## Most influential descendants
- K251207: Sangria™ Thrombectomy System (2026), 0 descendants of its own
- K251312: Vesalio Peripheral System (2025), 0 descendants of its own

## Indications for use
The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Source page: https://510kreport.com/device/K193197
Methodology: https://510kreport.com/methodology