PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER— 510(k) K052757

Name: FDA 510(k) clearance K052757
Creator: U.S. Food and Drug Administration
Published: 2005-10-28

Substantially Equivalent

Biotronik AG

FDA 510(k) clearance K052757 for PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, Substantially Equivalent on 2005-10-28. Applicant: Biotronik AG. Device class: 2.

Clearance details

Applicant: Biotronik AG
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2005-09-30
Decision date: 2005-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter +2 more2025-02-27

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.