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Advanced Cardiovascular Sys Low Profile Pta Balloo

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851854

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K851854 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)

This device is a catheter, angioplasty, peripheral, transluminal, as defined in the device type and nomenclature. It is a low profile PTA balloon designed for percutaneous transluminal angioplasty procedures.

It is supplied by Advanced Cardiovascular Systems, Inc., has FDA 510(k) clearance under K851854, and is classified as a Class II medical device with product code LIT. The device is intended for use in cardiovascular peripheral vascular interventions.

Frequently asked questions

What is the Advanced Cardiovascular Systems Low Profile PTA Balloon used for?

This device is a catheter designed for percutaneous transluminal angioplasty procedures in peripheral vascular interventions. It is specifically a low profile PTA balloon intended to dilate narrowed or blocked peripheral arteries to restore blood flow during cardiovascular treatments.

How is the Advanced Cardiovascular Systems Low Profile PTA Balloon supplied and is it sterile?

The device is supplied by Advanced Cardiovascular Systems, Inc. While the provided data does not explicitly state sterility or single-use status, as a catheter-based angioplasty device with FDA 510(k) clearance, it is typically supplied sterile and intended for single-use during percutaneous transluminal angioplasty procedures to ensure patient safety and prevent cross-contamination.

What regulatory clearance does the Advanced Cardiovascular Systems Low Profile PTA Balloon have?

The device has FDA 510(k) clearance under submission number K851854, which was granted on August 5, 1985. It is classified as a Class II medical device with product code LIT and was determined to be substantially equivalent to a predicate device through the traditional 510(k) pathway.

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: Advanced Cardiovascular Sys Low Profile Pta Balloo, ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO… - FDA.report, ADV CARDIO SYS DBL LUMEN BALLOON DILATA... (K844972) - FDA 510(k), Low Profile Steerable Balloon Dilation 510 (k) FDA Premarket ..., PDF Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter

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) K851854 24 fields · synced Sep 25, 2026