# K181529: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

- Pathway: 510(k) (Traditional)
- Applicant: Contego Medical, LLC
- Decided: Dec 6, 2018 after 178 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003992 (2001). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172494: PROTEUS PTA Balloon Catheter with Embolic Capture Feature, Angioslide, Ltd. (2017) Summary page 4.
- K111010: Spiderfx Embolic Protection Device, Ev3, Inc. (2011) Summary page 4.

## Indications for use
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.

Source page: https://510kreport.com/device/K181529
Methodology: https://510kreport.com/methodology