ELM PTA Balloon Dilatation Catheter— 510(k) K143561

Name: FDA 510(k) clearance K143561
Creator: U.S. Food and Drug Administration
Published: 2015-05-19

Substantially Equivalent

O'Connell Regulatory Consultants, Inc.

FDA 510(k) clearance K143561 for ELM PTA Balloon Dilatation Catheter, Substantially Equivalent on 2015-05-19. Applicant: O'Connell Regulatory Consultants, Inc.. Device class: 2.

Clearance details

Applicant: O'Connell Regulatory Consultants, Inc.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2014-12-16
Decision date: 2015-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, US

Download summary PDF View on FDA.gov ↗

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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

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.