# K212894: PhasTIPP

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Mar 31, 2022 after 202 days
- Product code: DWQ (Stripper, Vein, External)
- Device class: 2
- Regulation: 21 CFR 870.4885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964561 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032387: Trivex System, Smith & Nephew, Inc. (2003) Summary page 5.

## Indications for use
The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.

Source page: https://510kreport.com/device/K212894
Methodology: https://510kreport.com/methodology