# K172716: V2K Rinspiration System

- Pathway: 510(k) (Traditional)
- Applicant: V2k Medical, Inc.
- Decided: Jan 26, 2018 after 140 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 K904788 (1990). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135, Kerberos Proximal Solutions, Inc. (2006) Summary page 4.

## Indications for use
The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.

Source page: https://510kreport.com/device/K172716
Methodology: https://510kreport.com/methodology