# K140943: Mastro Plus Balloon in-Deflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Demax Medical Technology Co.,Ltd
- Decided: Mar 5, 2015 after 325 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943597 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130566: Basixtouch, Merit Medical Systems, Inc. (2013) Summary page 6.
- K993341: Intellisystem II Color Monitor, Merit Medical Systems, Inc. (1999) Summary page 6.
- K032840: Atrion Medical QL Inflation Device, Atrion Medical Products, Inc. (2004) Summary page 6.

## Indications for use
The Balloon In-deflation device is used for the inflation and deflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

Source page: https://510kreport.com/device/K140943
Methodology: https://510kreport.com/methodology