AngioSculpt PTA Scoring Baloon Catheters— 510(k) K150634

Substantially Equivalent

Spectranetrics

FDA 510(k) clearance K150634 for AngioSculpt PTA Scoring Baloon Catheters, Substantially Equivalent on 2015-04-08. Applicant: Spectranetrics.

Clearance details

Applicant: Spectranetrics
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2015-03-11
Decision date: 2015-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

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.