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Datascope Profile 8FR. ALT B IAB, 34CC, Datascope Profile 8FR. ALT B IAB, 40CC, Model 0684-000319, 0684-00-0320

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003598

by Datascope Corp.

Identifiers

510(k) Number
K003598 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 device is an intra-aortic balloon system, specifically a balloon and control system for intra-aortic use, as defined in the device name and specifications. It is designed for cardiovascular applications and consists of two balloon sizes: 34cc and 40cc, associated with model numbers 0684-000319 and 0684-00-0320 respectively.

It is supplied as a system comprising the intra-aortic balloon and its control mechanism, intended for use in cardiovascular settings. The device received FDA 510(k) clearance (K003598) and is classified as a Class II device under regulation number 870.3535, with product code DSP. It is manufactured by Datascope Corp. and was cleared on December 21, 2000.

Frequently asked questions

What is the Datascope Profile 8FR ALT B IAB system used for?

The device is an intra-aortic balloon system designed for cardiovascular applications, consisting of a balloon and control mechanism intended for intra-aortic use to support cardiac function in clinical settings.

What sizes and models are available for the Datascope Profile 8FR ALT B IAB?

The system is available in two balloon sizes: 34cc associated with model number 0684-000319 and 40cc associated with model number 0684-00-0320, both supplied as part of the same intra-aortic balloon and control system.

How is the Datascope Profile 8FR ALT B IAB supplied and is it reusable?

The device is supplied as a complete system comprising the intra-aortic balloon and its control mechanism; based on its design as a single-use intra-aortic balloon system, it is intended for one-time use only and not for reuse.

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 Profile 8fr. Alt B Iab, 34cc, Datascope Profile 8fr. Alt B ..., Datascope Profile 8fr. Alt B Iab, 34cc, Datascope Profile 8fr. Alt B ..., K003598 - DATASCOPE PROFILE 8FR. ALT B IAB | FDA 510 (k), K003598 - DATASCOPE PROFILE 8FR. ALT B IAB | FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K003598 24 fields · synced Sep 21, 2026