# K123544: Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Feb 12, 2013 after 85 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: 7 generations back to K001134 (2000). 19 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082854: Nanocorss .014 Otw Pta Dilatation Catheter, Ev3, Inc. (2008) Summary page 1.
- K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150, Ev3, Inc. (2009) Summary page 1.
- K093286: Powercross .018 Otw Pta Dilation Catheter, Ev3, Inc. (2009) Summary page 1.
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.
- K090822: Advance 14RX Rapid Exchange Pta Balloon Catheter, Cook, Inc. (2009) Summary page 1.

## Most influential descendants
- K130911: Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter (2013), 7 descendants of its own
- K132777: Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter (2013), 6 descendants of its own
- K141118: Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter (2014), 5 descendants of its own
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (2016), 1 descendant of its own
- K142459: Ebony PTA 0.014 RX Peripheral Dilatation Catheter (2015), 1 descendant of its own

## Indications for use
The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K123544
Methodology: https://510kreport.com/methodology