Passeo-35 Xeo Peripheral Dilatation Catheter— 510(k) K222065

Name: FDA 510(k) clearance K222065
Creator: U.S. Food and Drug Administration
Published: 2023-02-16

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K222065 for Passeo-35 Xeo Peripheral Dilatation Catheter, Substantially Equivalent on 2023-02-16. Applicant: Biotronik, Inc.. Device class: 2.

Clearance details

Applicant: Biotronik, Inc.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2022-07-13
Decision date: 2023-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIT

view all

K260304 — WAVE PTA Balloon Catheter2026-05-20
K252512 — Armada 14 NC PTA Catheter2026-02-13
K251915 — Amethyst HP PTA OTW 0.035 Catheter2025-12-18
K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter +5 more2025-04-04
K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter +2 more2025-02-27

More clearances from Biotronik, Inc.

view all

K261074 — BIOMONITOR IV (471155)2026-05-01
K242969 — Pantera Pro; Pantera LEO2024-10-25
K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791) +2 more2024-09-12
K241711 — Oscar Peripheral Multifunctional Catheter system2024-07-11
K230375 — BIOMONITOR IV2023-05-19

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.