Cirqlator Intrathoracic Pressure Regulator (ITPR)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070490 FDA 510(k)
- FDA Product Code
- BWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5690 FDA 510(k)
- Regulation Number
- 868.5690 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cirqlator Intrathoracic Pressure Regulator (ITPR) is a device that temporarily decreases intrathoracic pressure to increase blood circulation. It is designed to regulate air pressure inside the chest cavity and is intended for use as prescribed by a physician, licensed practitioner, or qualified technician.
The device is supplied by Advanced Circulatory Systems Inc and has FDA 510(k) clearance with the product code BWF. It is indicated for temporary use with a recommended duration of up to four hours. The device is classified under device class 2 and is registered under the medical specialty of Anesthesiology.
Frequently asked questions
What is the Cirqlator Intrathoracic Pressure Regulator used for?
The Cirqlator ITPR is a device that temporarily decreases intrathoracic pressure to increase blood circulation. It is designed to regulate air pressure inside the chest cavity and is intended for use as prescribed by a physician, licensed practitioner, or qualified technician.
How is the Cirqlator ITPR supplied and what is its recommended duration of use?
The device is supplied by Advanced Circulatory Systems Inc and has FDA 510(k) clearance. It is indicated for temporary use with a recommended duration of up to four hours.
What is the regulatory classification of the Cirqlator ITPR?
The Cirqlator ITPR is classified under device class 2 and is registered under the medical specialty of Anesthesiology. It received FDA 510(k) clearance with the product code BWF in 2007.
Is the Cirqlator ITPR reusable or single-use?
The device information does not specify whether the Cirqlator ITPR is reusable or single-use. Users should consult the manufacturer's instructions for specific guidance on device usage and disposal.
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: Cirqlator Intrathoracic Pressure Regulator (Itpr), Cirqlator Intrathoracic Pressure Regulator (Itpr), Intrathoracic Pressure Regulator During Continuous-Chest-Compression ..., ADVANCED CIRCULATORY SYSTEMS, INC. - Device Creates Vacuum in Chest to ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070490 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Circulatory Systems Inc
- FDA Applicant
- Advanced Circulatory Systems, Inc.
Sources (1)
- FDA 510(k) K070490 24 fields · synced Sep 21, 2026