# K033217: Pheron Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Oct 31, 2003 after 28 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 2 generations back to K000101 (2000). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010838: Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004, A14005, A14006, A14007, A14008, Jomed AG (2001) Summary page 1.
- K020854: Modification to Fox Pta Catheter, Jomed AG (2002) Summary page 1.

## Most influential descendants
- K072765: Passeo 18 (2007), 7 descendants of its own
- K082933: Passeo-35 Pta Catheter (2008), 5 descendants of its own
- K142379: Passeo-35 PTA Catheter (2014), 3 descendants of its own
- K222065: Passeo-35 Xeo Peripheral Dilatation Catheter (2023), 1 descendant of its own
- K151744: Passeo-18 Peripheral Dilation Catheter (2015), 1 descendant of its own

## Indications for use
The Pheron PTA balloon catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K033217
Methodology: https://510kreport.com/methodology