# K160985: Pantera Pro

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Oct 7, 2016 after 182 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- 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 P790017 (1980). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 4.
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon, Medtronic, Ireland (2010) Summary page 4.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 4.

## Most influential descendants
- K163660: Pantera LEO (2017), 2 descendants of its own
- K242969: Pantera Pro; Pantera LEO (2024), 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

## Indications for use
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/K160985
Methodology: https://510kreport.com/methodology