# K103464: Pacific Xtreme Ptca Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 22, 2010 after 28 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042537 (2004). 9 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042537: Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx, Invatec Innovative Technologies (2004) Summary page 2.
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2009) Summary page 2.
- K100921: Admiral Xtreme Pta Balloon Dilatation Catheter, Invatec S.P.A. (2010) Summary page 2.

## Most influential descendants
- K133843: Saber Percutaneous Transluminal Angioplasty Dilatation Catheter (2014), 6 descendants of its own
- K151153: Pirouette 018 (2015), 4 descendants of its own
- K162316: Pirouette 014 (2016), 2 descendants of its own
- K161427: Pirouette 035 (2016), 2 descendants of its own
- K173621: Advocate PTA Catheter (2017), 1 descendant of its own

## Recalls of this device
- Aug 26, 2020 · Class II · Z-3055-2020: Labeling discrepancy for the Rated Burst Pressure (RBP) value.

## Indications for use
The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.

Source page: https://510kreport.com/device/K103464
Methodology: https://510kreport.com/methodology