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Datascope Percor Stat DL 10.5 Fr 50CC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K903930

by Datascope Corp.

Identifiers

510(k) Number
K903930 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 Percor Stat DL 10.5 Fr 50cc is an intra-aortic balloon pump system designed to assist cardiac function by inflating and deflating a balloon within the aorta. This device is intended for temporary mechanical circulatory support, improving coronary and systemic perfusion during acute myocardial infarction or cardiogenic shock.

This intra-aortic balloon system is supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA regulation 870.3535 and received FDA 510(k) clearance (K903930) in 1990. The device features a 10.5 French catheter with a 50cc balloon and is intended for use in controlled clinical settings, such as cardiac catheterization labs or intensive care units, where precise hemodynamic support is required.

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 PERCOR STAT DL 10.5 FR 50CC - Innolitics, K903930 FDA 510(k) - DATASCOPE PERCOR STAT DL 10.5 FR 50CC, K903930 FDA 510(k) - DATASCOPE PERCOR STAT DL 10.5 FR 50CC, DATASCOPE PERCOR STAT DL 10.5 FR 50CC 510 (k) K903930 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K903930 24 fields · synced Oct 1, 2026