SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH— 510(k) K912317

Name: FDA 510(k) clearance K912317
Creator: U.S. Food and Drug Administration
Published: 1991-08-22

Substantially Equivalent

Schneider Intl., Ltd.

FDA 510(k) clearance K912317 for SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH, Substantially Equivalent on 1991-08-22. Applicant: Schneider Intl., Ltd.. Device class: 2.

Clearance details

Applicant: Schneider Intl., Ltd.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1991-05-24
Decision date: 1991-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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 Schneider Intl., Ltd.

view all

K925406 — BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM1995-01-11
K931577 — SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI1993-06-23
K926003 — SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER1993-06-07
K926271 — SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO1993-06-07
K925804 — SCHNEIDER HYDRO-SIL GUIDEWIRE1993-02-12

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.