Leocor Corflo Pump -- Modification
by Leocor, Inc.
510(k) K924110
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924110 | Date1 Sep 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Leocor Corflo Pump — Modification is a Withdrawal/Infusion Pump (Device Class II), designed for controlled fluid administration or removal in cardiovascular applications. It facilitates precise volumetric delivery or aspiration of liquids, ensuring accurate dosing or drainage in clinical settings where fluid management is critical.
This device is supplied as a reusable medical instrument, intended for use in regulated healthcare environments. It carries an FDA 510(k) clearance (K924110) under the DQI product code, with a Substantially Equivalent determination by the Cardiovascular Advisory Committee. No third-party reprocessing is indicated, and its use must comply with standard infection control protocols for reusable devices.
Other devices from Leocor, Inc.
Questions
AI-generated answers, 19 Sep 2026
Is the Leocor Corflo Pump — Modification intended for single-use or can it be reused in a clinical setting?
The Leocor Corflo Pump — Modification is designed as a reusable medical instrument, meaning it is meant to be used multiple times in regulated healthcare environments. However, reuse must strictly follow standard infection control protocols to ensure patient safety, as no third-party reprocessing is indicated for this device.
What types of clinical applications is the Leocor Corflo Pump — Modification approved for, and why?
This pump is specifically cleared for controlled fluid administration or removal in cardiovascular applications, such as precise volumetric delivery or aspiration of liquids. Its approval under the DQI product code (Withdrawal/Infusion Pump) and review by the Cardiovascular Advisory Committee confirms its intended use in scenarios requiring accurate fluid management, like drainage or infusion in cardiac procedures.
How was the FDA clearance for this device determined, and what does that mean for its regulatory status?
The Leocor Corflo Pump — Modification received a Substantially Equivalent (SESE) determination from the FDA via a Traditional 510(k) pathway, meaning it was found to be as safe and effective as a legally marketed predicate device. This classification places it in Device Class II, indicating it undergoes stricter regulatory oversight than Class I but not as rigorous as Class III.
What should clinicians consider when storing or preparing the Leocor Corflo Pump — Modification for use?
Since this is a reusable device, clinicians must adhere to standard infection control protocols during storage and reprocessing to maintain sterility and safety. The pump should be cleaned, disinfected, and stored in a manner that prevents contamination between uses, as no third-party reprocessing is authorized for this specific model.
Are there different models or sizes available for the Leocor Corflo Pump — Modification, and if so, how would a buyer determine the right fit?
The provided data does not specify distinct models or sizes for this particular modification of the Corflo Pump. However, since it is a Withdrawal/Infusion Pump designed for cardiovascular applications, buyers should consult Leocor’s technical documentation or support team to confirm compatibility with their specific clinical workflows or patient needs, particularly regarding flow rates or tubing requirements.