# K214038: Oscar Peripheral Multifunctional Catheter system

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jul 6, 2022 after 195 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: 7 generations back to K001134 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192399: Infinity Angioplasty Balloon Catheter, Infinity Angioplasty Balloon Company, LLC (2020) Summary page 4.

## Most influential descendants
- K241711: Oscar Peripheral Multifunctional Catheter system (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 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.

Source page: https://510kreport.com/device/K214038
Methodology: https://510kreport.com/methodology