# K082933: Passeo-35 Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Nov 3, 2008 after 33 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: 4 generations back to K000101 (2000). 7 ancestors in all.
5 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)
- K033217: Pheron Pta Catheter, Biotronik, Inc. (2003) Summary page 1.
- K052757: Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) Catheter, Biotronik AG (2005) Summary page 1.
- K072765: Passeo 18, Biotronik, Inc. (2007) Summary page 1.

## Most influential descendants
- K142379: Passeo-35 PTA Catheter (2014), 3 descendants of its own
- K222065: Passeo-35 Xeo Peripheral Dilatation Catheter (2023), 1 descendant of its own
- K152240: Passeo-14 Peripheral Dilatation Catheter (2015), 1 descendant of its own
- K250706: Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (2025), 0 descendants of its own
- K130161: Passeo-35 (2013), 0 descendants of its own

## Indications for use
The Passeo-35 peripheral dilatation 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/K082933
Methodology: https://510kreport.com/methodology