# K102645: Willow/Elm Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Creagh Medical, Ltd.
- Decided: Dec 10, 2010 after 88 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: 3 generations back to K042537 (2004). 8 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050073: Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K052791: Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K042624: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2009) Summary page 1.
- K073472: Vaccess Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2008) Summary page 1.

## Most influential descendants
- K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (2017), 2 descendants of its own
- K200700: Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter (2020), 1 descendant of its own
- K230191: Arise™ UHP Dilatation Catheter (2023), 0 descendants of its own
- K211044: Sublime Radial Access 018 RX Dilatation Catheter (2021), 0 descendants of its own
- K143561: ELM PTA Balloon Dilatation Catheter (2015), 0 descendants of its own

## Indications for use
The WILLOW PTA 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. The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K102645
Methodology: https://510kreport.com/methodology