# K120164: Proteus Pta Balloon Catheter with Embolic Capture Feature

- Pathway: 510(k) (Traditional)
- Applicant: Angioslide, Ltd.
- Decided: Jun 8, 2012 after 141 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: 8 generations back to K003992 (2001). 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)
- K111750: Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature, Angioslide, Ltd. (2011) Summary page 10.

## Indications for use
The Angioslide PROTEUS Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries. The Angioslide PROTEUS PTA Balloon Catheter with Embolic Capture Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.

Source page: https://510kreport.com/device/K120164
Methodology: https://510kreport.com/methodology