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Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K844972

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K844972 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, designed for use in cardiovascular procedures. It features a double lumen balloon configuration for dilatation applications.

It is supplied as a reusable device, cleared under FDA 510(k) K844972, and classified as a Class II medical device with product code LIT. The device is intended for use in peripheral transluminal angioplasty procedures.

Frequently asked questions

What is the ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER used for?

This device is designed for use in peripheral transluminal angioplasty procedures, featuring a double lumen balloon configuration specifically intended for dilatation applications in cardiovascular interventions.

Is the ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER reusable or single-use?

The device is supplied as a reusable catheter, meaning it can be cleaned, sterilized, and used multiple times following appropriate reprocessing protocols, as indicated in its FDA 510(k) clearance documentation.

What regulatory pathway was used for the ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER?

The device received clearance through the FDA 510(k) pathway under submission K844972, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device with product code LIT.

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: Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter, ADV CARDIO SYS DBL LUMEN BALLOON DILATA... (K844972) - FDA 510(k), PDF K844972 - Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter, Advanced Cardiovascular Balloon Dilata 510 (k) FDA Premarket ..., K842556 FDA 510 (k) - ADVANCED CARDIOVASCULAR BALLOON DILATA

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) K844972 24 fields · synced Sep 27, 2026