# K120805: Proteus Pta Balloon Catheter with Embolic Capture Feature

- Pathway: 510(k) (Special)
- Applicant: Angioslide, Ltd.
- Decided: Apr 13, 2012 after 28 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). 19 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 23 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 2.
- K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario, Boston Scientific Corp (2009) Summary page 2.

## Most influential descendants
- K133043: Proteus Pta Balloon Catheter with Embolic Capture Feature (2013), 2 descendants of its own
- K172494: PROTEUS PTA Balloon Catheter with Embolic Capture Feature (2017), 1 descendant of its own
- K181529: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection (2018), 0 descendants of its own

## 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/K120805
Methodology: https://510kreport.com/methodology