Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter— 510(k) K200700

Name: FDA 510(k) clearance K200700
Creator: U.S. Food and Drug Administration
Published: 2020-05-14

Substantially Equivalent

Creagh Medical, Ltd.

FDA 510(k) clearance K200700 for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter, Substantially Equivalent on 2020-05-14. Applicant: Creagh Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Creagh Medical, Ltd.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2020-03-17
Decision date: 2020-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballinasloe, IE

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 Creagh Medical, Ltd.

view all

K230191 — Arise UHP Dilatation Catheter2023-03-22
K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter2018-04-19
K113468 — ELM PTA BALLON DILATATION CATHETER2011-12-20
K102645 — WILLOW/ELM PTA BALLOON DILATATION CATHETER2010-12-10

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.