510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K150634Substantially Equivalent

AngioSculpt PTA Scoring Baloon Catheters

Spectranetrics, Colorado Springs CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150634 is the FDA 510(k) clearance record for AngioSculpt PTA Scoring Baloon Catheters, a class II device, cleared for Spectranetrics on under FDA product code PNO (Catheter, Percutaneous, Cutting/Scoring). FDA's definition for product code PNO reads: "To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material". FDA records list one 510(k) clearance for Spectranetrics. As of , FDA records show no recalls naming K150634.

Clearance record

Decision date
Received
(28 days to decision)
Product code
PNO Catheter, Percutaneous, Cutting/Scoring
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectranetrics 9965 Federal Dr., Colorado Springs CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNO

Trailing 12 months
2 clearances under product code PNO in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260