# K231148: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm

- Pathway: 510(k) (Traditional)
- Applicant: Vvt Medical, Ltd.
- Decided: Jun 20, 2023 after 60 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201907: ClariVein IC, Merit Medical Systems, Inc. (2020) Summary page 4.

## Indications for use
ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

Source page: https://510kreport.com/device/K231148
Methodology: https://510kreport.com/methodology