SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE— 510(k) K113103

Substantially Equivalent

Rex Medical

FDA 510(k) clearance K113103 for SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE, Substantially Equivalent on 2012-05-22. Applicant: Rex Medical.

Clearance details

Applicant: Rex Medical
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2011-10-19
Decision date: 2012-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

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.