Identifiers
- 510(k) Number
- K001822 FDA 510(k)
- FDA Product Code
- DTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4400 FDA 510(k)
- Regulation Number
- 870.4400 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The V-Bag is a Blood, Cardiopulmonary Bypass Reservoir (DTN), designed as a soft-shell venous reservoir for use in extracorporeal circulation during cardiovascular procedures. It collects and temporarily stores venous and cardiotomy blood, facilitating efficient drainage and minimizing air entrainment during surgical support.
Supplied as a single-use, sterile disposable, the V-Bag is intended for use in controlled clinical settings such as operating rooms or cardiac catheterization labs. It is classified as a Class II device under FDA regulations (870.4400) and holds a FDA 510(k) clearance (K001822) for substantial equivalence in cardiovascular applications. No MRI safety or reusable specifications are indicated.
Frequently asked questions
What is the V-Bag used for in cardiovascular procedures?
The V-Bag is a soft-shell venous reservoir specifically designed for use in extracorporeal circulation during cardiovascular procedures. It collects and temporarily stores venous and cardiotomy blood, helping to ensure efficient drainage and minimize air entrainment during surgical support. This makes it ideal for controlled clinical settings like operating rooms or cardiac catheterization labs.
Is the V-Bag reusable or single-use?
The V-Bag is supplied as a single-use, sterile disposable device. This design ensures patient safety by preventing cross-contamination between procedures and reduces the risk of infection or device failure associated with reuse.
What are the key features that distinguish the V-Bag from other venous reservoirs?
The V-Bag is distinguished by its soft-shell design, which facilitates efficient blood drainage and minimizes air entrainment during cardiopulmonary bypass procedures. Unlike rigid reservoirs, its flexible construction allows for better adaptation to varying blood volumes and flow dynamics, enhancing usability in complex cardiovascular surgeries.
How should the V-Bag be stored before use?
The V-Bag should be stored in its original, sealed packaging to maintain sterility until use. It is critical to keep the device in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines to ensure the device remains uncontaminated and functional for its intended single-use application.
Does the V-Bag have any special considerations for MRI safety?
The V-Bag does not have any specified MRI safety information provided in its documentation. Clinicians should exercise caution and verify compatibility with MRI equipment and protocols before use in an MRI environment, as the device’s materials or components may not be MRI-safe.
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: Circulatory Technology Inc produces medical devices for cardiovascular ..., Vacuum Assist and the safety of a soft shell reservoir: V-Bag, THE V-BAG (K001822) — FDA 510(k) | Innolitics, V-BAG WITH GBS COATING (K050195) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001822 | Class II | Active |
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Manufacturer
- Manufacturer
- Circulatory Technology, Inc.
Sources (1)
- FDA 510(k) K001822 24 fields · synced Oct 1, 2026