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Angiosculpt PTA Scoring Balloon Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081220

by Angioscore, Inc.

Identifiers

510(k) Number
K081220 FDA 510(k)
FDA Product Code
PNO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Angiosculpt PTA Scoring Balloon Catheter is a percutaneous cutting and scoring catheter designed for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries. It features a semicompliant balloon with a helical nitinol element that provides controlled focal force to achieve uniform luminal enlargement and minimize device slippage during plaque modification.

This device is regulated as a Class 2 medical device under FDA 510(k) clearance. It is intended for use in cardiovascular procedures as specified in the product instructions. Users should refer to the manufacturer's manual for information regarding storage, sterility, and handling requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AngioSculpt PTA Scoring Balloon Catheter - Philips, Modification to Angiosculpt Pta Scoring Balloon Catheter (K081220 ..., Modification to Angiosculpt Pta Scoring Balloon Catheter, AngioScore AngioSculpt Instructions For Use Manual, AngioScore AngioSculpt Instructions For Use Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Angioscore, Inc.

Sources (1)

  • FDA 510(k) K081220 24 fields · synced Sep 23, 2026