# K072765: Passeo 18

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Dec 12, 2007 after 75 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 K000101 (2000). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033217: Pheron Pta Catheter, Biotronik, Inc. (2003) Summary page 1.
- K052757: Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) Catheter, Biotronik AG (2005) Summary page 1.

## Most influential descendants
- 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
- K152240: Passeo-14 Peripheral Dilatation Catheter (2015), 1 descendant of its own

## Indications for use
Passeo-18 is indicated to dilate stenosis in the 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/K072765
Methodology: https://510kreport.com/methodology