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Partner Seven Disp. Bubble Oxygenator

by Cardiovascular Research, Inc.

510(k) K800555

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800555 Date4 Apr 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Partner Seven Disposable Bubble Oxygenator is a bubble-type oxygenator used in cardiopulmonary bypass procedures. It facilitates the exchange of oxygen and carbon dioxide in blood during open-heart surgeries by passing blood through a chamber where it is aerated with oxygen bubbles, ensuring adequate oxygenation while the heart is temporarily stopped or bypassed.

This device is supplied as a disposable and is intended for single-use in controlled clinical settings such as operating rooms. It is classified under FDA Device Class II (DTZ) and has received FDA 510(k) clearance (K800555) as substantially equivalent to a predicate device. Regulated under 21 CFR 870.4350, it adheres to strict manufacturing and performance standards for oxygenators used in cardiovascular procedures.

Other devices from Cardiovascular Research, Inc.