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Percor 9.5 Fr IAB on Datascope CO2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K833828

by Datascope Corp.

Identifiers

510(k) Number
K833828 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 Percor 9.5 Fr IAB on Datascope CO2 is a System, Balloon, Intra-Aortic And Control device, designed for temporary mechanical circulatory support. It features an intra-aortic balloon pump (IABP) with a 9.5 French catheter, integrated with a CO₂ monitoring system to assist in managing cardiac output and oxygenation during acute myocardial ischemia or cardiogenic shock. The device operates by counterpulsation to enhance coronary and systemic perfusion, reducing myocardial oxygen demand and improving end-organ perfusion.

This device is intended for use in critical care settings, such as cardiac catheterization labs or intensive care units, where invasive hemodynamic monitoring is required. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K833828) and falls under product code DSP, classified as Class II with special controls. The 9.5 French size is specified for adult patients, and proper storage adheres to sterile packaging guidelines to maintain device integrity until use. No MRI safety information is provided in the available data.

Frequently asked questions

What is the primary clinical purpose of the Percor 9.5 Fr IAB with CO₂ monitoring, and where is it typically used?

The Percor 9.5 Fr IAB with CO₂ monitoring is designed for temporary mechanical circulatory support to assist patients experiencing acute myocardial ischemia or cardiogenic shock. It works by using an intra-aortic balloon pump (IABP) with a 9.5 French catheter to enhance coronary and systemic perfusion through counterpulsation. This improves oxygenation and reduces myocardial oxygen demand, making it ideal for critical care settings like cardiac catheterization labs or intensive care units where invasive hemodynamic monitoring is required.

Is this device intended for single-use or repeated use, and how should it be stored to maintain sterility?

The Percor 9.5 Fr IAB with CO₂ monitoring is supplied sterile and explicitly intended for single-use only. To preserve sterility, it must be stored according to the sterile packaging guidelines provided by the manufacturer, ensuring the device remains unopened and undamaged until use. Proper storage conditions prevent contamination and maintain device integrity.

What size catheter is included in this device, and is it suitable for pediatric or adult patients?

This device features a 9.5 French catheter, which is specifically sized for adult patients requiring temporary mechanical circulatory support. The larger French size is not designed for pediatric use, as it may not be appropriate for smaller patient anatomies or weight classes.

Does this device include any additional monitoring capabilities beyond the intra-aortic balloon pump?

Yes, the Percor 9.5 Fr IAB is integrated with a CO₂ monitoring system, which assists clinicians in managing cardiac output and oxygenation during critical interventions. This dual functionality helps optimize perfusion and reduce myocardial oxygen demand in patients with acute cardiac conditions.

What regulatory pathway was followed for this device’s approval, and what classification does it hold?

The Percor 9.5 Fr IAB with CO₂ monitoring was cleared through the FDA 510(k) pathway under the traditional review process, with a clearance number of K833828. It is classified as a Class II medical device under product code DSP, which includes special controls for intra-aortic balloon pumps. The device was reviewed by the Cardiovascular (CV) Advisory Committee and is substantively equivalent to prior generations.

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: PERCOR 9.5 FR IAB ON DATASCOPE CO2 (K833828) - FDA 510 (k), PERCOR 9.5 FR IAB ON DATASCOPE CO2 - Innolitics, PDF K833828 - Percor 9.5 Fr Iab on Datascope Co2, DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL… - FDA.report, FDA 510 (k) Applications Submitted by Datascope Corp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K833828 24 fields · synced Sep 20, 2026