# 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

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Apr 4, 2025 after 25 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: 9 generations back to K001134 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222065: Passeo-35 Xeo Peripheral Dilatation Catheter, Biotronik, Inc. (2023) Summary page 10.
- K151744: Passeo-18 Peripheral Dilation Catheter, Biotronik, Inc. (2015) Summary page 15.
- K152240: Passeo-14 Peripheral Dilatation Catheter, Biotronik, Inc. (2015) Summary page 21.
- K241711: Oscar Peripheral Multifunctional Catheter system, Biotronik, Inc. (2024) Summary page 26.
- K242969: Pantera Pro; Pantera LEO, Biotronik, Inc. (2024) Summary page 31.

## Indications for use
The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. The Passeo-18 peripheral dilatation catheter 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. Passeo-14 1s indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion. The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography. The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents. The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 — 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K250706
Methodology: https://510kreport.com/methodology