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Datascope 8.5 French Electrode Intra-Aortic Balloon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K850482

by Datascope Corp.

Identifiers

510(k) Number
K850482 FDA 510(k)
FDA Product Code
DSP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3535 FDA 510(k)
Regulation Number
870.3535 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Datascope 8.5 French Electrode Intra-Aortic Balloon is a system consisting of an inflatable balloon and control unit designed to improve cardiovascular functioning during certain life-threatening emergencies. The balloon is placed in the aorta to provide circulatory support when needed.

This device is supplied as part of a system classified under product code DSP with Class II special controls. It received FDA 510(k) clearance on August 22, 1985, with the clearance number K850482. The device is regulated under regulation number 870.3535.

Frequently asked questions

What is the purpose of the Datascope 8.5 French Electrode Intra-Aortic Balloon?

The Datascope 8.5 French Electrode Intra-Aortic Balloon is designed to improve cardiovascular functioning during certain life-threatening emergencies by providing circulatory support when placed in the aorta.

How is the Datascope 8.5 French Electrode Intra-Aortic Balloon supplied?

The device is supplied as part of a system classified under product code DSP with Class II special controls. It includes an inflatable balloon and control unit designed to work together for optimal performance.

What is the regulatory status of the Datascope 8.5 French Electrode Intra-Aortic Balloon?

The device received FDA 510(k) clearance on August 22, 1985, with clearance number K850482. It is regulated under regulation number 870.3535 and is classified as substantially equivalent.

Is the Datascope 8.5 French Electrode Intra-Aortic Balloon reusable or single-use?

The device data does not specify whether the Datascope 8.5 French Electrode Intra-Aortic Balloon is designed for single-use or reuse. This information would be detailed in the product's instructions for use provided by the manufacturer.

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: Datascope 8.5 French Electrode Intra-aortic Balloo, K850482 FDA 510(k) - DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AO..., DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO 510 (k) K850482 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K850482 24 fields · synced Sep 25, 2026