SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER— 510(k) K872542

Name: FDA 510(k) clearance K872542
Creator: U.S. Food and Drug Administration
Published: 1987-09-14

Substantially Equivalent

Angiomedics, Inc.

FDA 510(k) clearance K872542 for SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER, Substantially Equivalent on 1987-09-14. Applicant: Angiomedics, Inc.. Device class: 2.

Clearance details

Applicant: Angiomedics, Inc.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1987-06-29
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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 Angiomedics, Inc.

view all

K873195 — SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO1987-12-15
K872472 — SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE1987-09-14
K863342 — SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER1987-03-03
K861238 — ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV1986-07-16
K852872 — ANGIOMEDICS SOFTIP CATHETER1985-10-11

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.