Venacure 1470 Pro

Quanta System Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K181632
Device name
Venacure 1470 Pro
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-06-20
Decision date
2018-09-17
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Vascular treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

Venacure 1470 Pro is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Intended Use

Venacure 1470 Pro is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Summary parsed at:2026-06-01 05:57:47 UTC

Predicate devices

0

No predicate K numbers were extracted

The Summary PDF may not be parsed yet, or this submission may not cite predicate devices

Cited as predicate

1

1 submission cite K181632 as a predicate