# K012480: Vanguard Reprocessed Inflation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Jan 22, 2002 after 173 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACS Indeflator™ Inflation Devices: named in the summary without a submission number
- (no number) Medtronic Everest™ 20/30 Inflation Devices: named in the summary without a submission number
- (no number) Merit Medical Systems Monarch™/ IntelliSystem®25 Inflation Devices: named in the summary without a submission number
- (no number) SCIMED® Encore® 26 Inflation Devices: named in the summary without a submission number

## Indications for use
The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon.

Source page: https://510kreport.com/device/K012480
Methodology: https://510kreport.com/methodology