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V-Bag Blood Reservoir

by Circulatory Technology, Inc.

510(k) K001822

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001822 Date7 Jul 2000ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
The V-Bag
510(k) Number
FDA product code
DTN
Device class
Class II
Regulation
21 CFR Part 870.4400
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass).

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