# V-Bag Blood Reservoir

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/the-v-bag-dtn>
- Manufacturer: [Circulatory Technology, Inc.](https://devicerts.com/manufacturers/circulatory-technology-inc) (United States, FDA 510(k) applicant)
- Name in the registry: THE V-BAG
- Device class: Class II (US FDA)
- FDA product code: DTN

## Overview

*AI-generated summary, 2026-10-01. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K001822 · decision 2000-07-07 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K001822 [FDA 510(k)]
- FDA product code: DTN [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 870.4400 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: V-Bag Blood Reservoir, Circulatory Technology, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/the-v-bag-dtn (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/the-v-bag-dtn.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/the-v-bag-dtn
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.