# K201216: CAPERE Thrombectomy System

- Pathway: 510(k) (Special)
- Applicant: Vascular Medcure, Inc.
- Decided: Jul 8, 2020 after 64 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- 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: 7 generations back to K832023 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192935: CAPERE Thrombectomy System, Vascular Medcure, Inc. (2019) Summary page 4.

## Indications for use
The CAPERE® Thrombectomy System is indicated for: -Non-surgical removal of soft emboli and thrombi from blood vessels. -Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

Source page: https://510kreport.com/device/K201216
Methodology: https://510kreport.com/methodology