DRY · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4330 · Class 2
Overview
| Product Code | DRY |
|---|---|
| Device Name | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4330 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | Apr 25, 2024 | SESE |
| K202154 | B-Capta | Livanova Deutschland, GmbH | Apr 1, 2021 | SESE |
| K202557 | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | Oct 2, 2020 | SESE |
| K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | Nov 2, 2018 | SESE |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | Aug 17, 2018 | SESE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical , Ltd. | Mar 28, 2018 | SESE |
| K163657 | Quantum Workstation | Spectrum Medical , Ltd. | Jan 18, 2017 | SESE |
| K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | Medtronic, Inc. | Oct 23, 2014 | SESE |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | Jul 25, 2014 | SESE |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | Nov 20, 2012 | SESE |
| K110957 | M4 MONITOR | Spectrum Medical, Llp | May 31, 2011 | SESE |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | Sorin Group Deutschland GmbH | Jan 6, 2011 | SESE |
| K091908 | M3 MONITOR | Spectrum Medical , Ltd. | Jul 10, 2009 | SESE |
| K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 | Maquet Cardiopulmonary, AG | Apr 22, 2009 | SESE |
| K072131 | M3 MONITOR | Spectrum Medical , Ltd. | Aug 17, 2007 | SESE |
| K071725 | M2 MONITOR | Spectrum Medical , Ltd. | Jul 11, 2007 | SESE |
| K062468 | SPECTRUM M2 MONITOR | Spectrum Medical, Llp | Sep 13, 2006 | SESE |
| K012743 | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | Medtronic Perfusion Systems | Sep 14, 2001 | SESE |
| K001388 | DATA MASTER PERFUSION MONITORING SYSTEM | Dideco | Jul 28, 2000 | SESE |
| K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | 3M Healthcare | May 15, 1998 | SESE |
Top Applicants
- Spectrum Medical , Ltd. — 7 clearances
- 3M Company — 3 clearances
- 3M Healthcare — 2 clearances
- Cardiovascular Devices, Inc. — 2 clearances
- International Biophysics Corp. — 2 clearances
