AngioSculpt PTA Scoring Baloon Catheters— 510(k) K150634

Name: FDA 510(k) clearance K150634
Creator: U.S. Food and Drug Administration
Published: 2015-04-08

Substantially Equivalent

Spectranetrics

FDA 510(k) clearance K150634 for AngioSculpt PTA Scoring Baloon Catheters, Substantially Equivalent on 2015-04-08. Applicant: Spectranetrics. Device class: 2.

Clearance details

Applicant: Spectranetrics
Product code: Code PNO
Device class: Class 2
Regulation: 21 CFR 870.1250
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 ↗

Recent devices under product code PNO

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K261778 — JADE SCORE PTA Scoring Balloon Dilatation Catheter2026-09-16
K260012 — UltraScore Focused Force PTA Balloon2026-02-04
K243944 — Aperta NSE PTA Balloon Dilatation Catheter2025-04-22
K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter2025-04-21
K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter2024-10-22

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.