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Percor Stat DL 9.5 Fr 40CC Intra-Aortic Balloon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920427

by Datascope Corp.

Identifiers

510(k) Number
K920427 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 Stat DL 9.5 Fr 40cc Intra-Aortic Balloon is a System, Balloon, Intra-Aortic And Control device, classified under FDA product code DSP. This device consists of an inflatable balloon designed for placement within the aorta to augment cardiac output during critical cardiovascular emergencies. The balloon operates in synchronization with the patient’s cardiac cycle to improve perfusion and reduce myocardial oxygen demand.

The device is supplied as a single-use, sterile system and is intended for use in intensive care or cardiac catheterization laboratories. It requires no special MRI safety considerations and is available in the specified size (9.5 Fr, 40cc). Storage instructions are not detailed in the data, but standard sterile medical device protocols apply. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of August 3, 1993, and is regulated under FDA regulation number 870.3535.

Frequently asked questions

What is the Percor Stat DL 9.5 Fr Intra-Aortic Balloon used for?

The Percor Stat DL 9.5 Fr Intra-Aortic Balloon is designed for placement within the aorta to improve blood flow and reduce the heart’s oxygen demand during critical cardiovascular emergencies. By inflating and deflating in sync with the patient’s heartbeat, it augments cardiac output, supporting patients in intensive care or cardiac catheterization labs.

Is the Percor Stat DL 9.5 Fr Intra-Aortic Balloon single-use or reusable?

This device is supplied as a single-use system. It is intended for one-time use per patient to ensure sterility and safety, adhering to standard medical device protocols for sterile procedures.

What size and capacity does the Percor Stat DL 9.5 Fr Intra-Aortic Balloon have?

The Percor Stat DL 9.5 Fr Intra-Aortic Balloon features a 9.5 French (Fr) diameter and a 40cc balloon capacity, making it suitable for specific patient anatomies and clinical needs in critical care settings.

Does this device require any special storage instructions?

While specific storage instructions are not detailed in the provided data, standard sterile medical device protocols should be followed. This includes keeping the device in a clean, dry environment, protected from contamination, and adhering to manufacturer guidelines for shelf life.

Is the Percor Stat DL 9.5 Fr Intra-Aortic Balloon compatible with MRI?

No special MRI safety considerations are mentioned for this device, indicating it is not designed for use in MRI environments. Always verify compatibility with your facility’s MRI safety protocols before use.

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 9.5 Fr 40cc Intra-aor Bal (K904018) — Fda 510 ..., K940178 FDA 510(k) - PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERC..., PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON… - 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) K920427 24 fields · synced Oct 1, 2026