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Acs Schwarten Xt Balloon Dilatation Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K882925

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K882925 FDA 510(k)
FDA Product Code
LIT 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 Acs Schwarten Xt Balloon Dilatation Catheter is a peripheral transluminal angioplasty catheter designed to deliver a balloon for dilating stenotic vessels. It belongs to the catheter family used in cardiovascular interventions to restore vessel patency.

The device is marketed by Advanced Cardiovascular Systems, Inc. and is identified by the FDA 510(k) number K882925. It is classified as a Class II device (product code LIT) and was cleared through a traditional 510(k) submission under 21 CFR 870.1250.

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: ACS SCHWARTEN XT BALLOON DILATATION CATHETER (K882925) — FDA 510 (k ..., ACS SCHWARTEN XT BALLOON DILATATION CATHETER 510(k) K882925 - fda.report, Coronary Dilatation Catheters | Abbott, ACS: High Precision Motion Control Systems & Solutions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Cardiovascular Systems, Inc.

Sources (1)

  • FDA 510(k) K882925 24 fields · synced Sep 23, 2026