# K090364: Extra Pta Balloon Catheter with Embolic Protection Feature

- Pathway: 510(k) (Traditional)
- Applicant: Angioslide, Ltd.
- Decided: Mar 23, 2010 after 403 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: 6 generations back to K003992 (2001). 10 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023320: Agiltrac .035 Peripheral Dilatation Catheter, Guidant Corp. (2002) Summary page 1.
- K052036: Atb Advance Pta Dilatation Catheter, Cook, Inc. (2005) Summary page 1.
- K063785: Spiderfx Embolic Protection Device, Ev3, Inc. (2007) Summary page 2.

## Most influential descendants
- K111750: Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter with Embolic Capture Feature (2011), 5 descendants of its own
- K111010: Spiderfx Embolic Protection Device (2011), 4 descendants of its own
- K120805: Proteus Pta Balloon Catheter with Embolic Capture Feature (2012), 3 descendants of its own
- K180023: Wirion (2018), 2 descendants of its own
- K133043: Proteus Pta Balloon Catheter with Embolic Capture Feature (2013), 2 descendants of its own

## Indications for use
Thle Angioslide eXtraTM Percutaneous Transluminal Angioolasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral translurninal anaioplasty and for capture and containment of embolic material during angioplasty. for the fernoral. iliac. ilio-femoral. popliteal. tibia]. peroneal, and profunda arteries. The Angioslide eXtraTM 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/K090364
Methodology: https://510kreport.com/methodology