# K130161: Passeo-35

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Apr 23, 2013 after 90 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: 5 generations back to K000101 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082933: Passeo-35 Pta Catheter, Biotronik, Inc. (2008) Summary page 1.

## 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/K130161
Methodology: https://510kreport.com/methodology