Product code DRY
- Device name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4330
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024-04-25 |
| K202154 | B-Capta | Livanova Deutschland, GmbH | 2021-04-01 |
| K202557 | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | 2020-10-02 |
| K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018-11-02 |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | 2018-08-17 |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical , Ltd. | 2018-03-28 |
| K163657 | Quantum Workstation | Spectrum Medical , Ltd. | 2017-01-18 |
| K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | Medtronic, Inc. | 2014-10-23 |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2014-07-25 |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2012-11-20 |
| K110957 | M4 MONITOR | Spectrum Medical, Llp | 2011-05-31 |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | Sorin Group Deutschland GmbH | 2011-01-06 |
| K091908 | M3 MONITOR | Spectrum Medical , Ltd. | 2009-07-10 |
| K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 | Maquet Cardiopulmonary, AG | 2009-04-22 |
| K072131 | M3 MONITOR | Spectrum Medical , Ltd. | 2007-08-17 |
| K071725 | M2 MONITOR | Spectrum Medical , Ltd. | 2007-07-11 |
| K062468 | SPECTRUM M2 MONITOR | Spectrum Medical, Llp | 2006-09-13 |
| K012743 | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | Medtronic Perfusion Systems | 2001-09-14 |
| K001388 | DATA MASTER PERFUSION MONITORING SYSTEM | Dideco | 2000-07-28 |
| K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | 3M Healthcare | 1998-05-15 |
| K973472 | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT | 3M Healthcare | 1997-12-08 |
| K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 | 3M Company | 1997-11-06 |
| K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | International Biophysics Corp. | 1996-05-14 |
| K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | International Biophysics Corp. | 1996-05-14 |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | Medtronic Bio-Medicus, Inc. | 1995-02-17 |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | 3M Health Care, Ltd. | 1993-11-10 |
| K915255 | CDI(TM) 300, 400 & 100, MODIFICATION | 3M Company | 1992-01-15 |
| K915265 | CDI(TM) H/S CUVETTE, MODIFICATION | 3M Company | 1992-01-15 |
| K910421 | SATURATION/HEMATOCRIT MONITOR SYSTEM | Medtronic Vascular | 1991-10-15 |
| K903729 | GOLD GATORS | Lead-Lok, Inc. | 1990-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000419936 | TMC50 | MEDTRONIC, INC. | 2021-09-18 |
| 00763000419929 | TMC38 | MEDTRONIC, INC. | 2021-09-18 |
| 00763000419912 | TMC25 | MEDTRONIC, INC. | 2021-09-18 |
| 08033178113106 | B-CAPTA | SORIN GROUP ITALIA SRL | 2021-05-05 |
| 08033178113526 | B-CAPTA | SORIN GROUP ITALIA SRL | 2021-05-05 |
| 08033178113090 | B-CAPTA | SORIN GROUP ITALIA SRL | 2021-05-05 |
| 08033178113113 | B-CAPTA | SORIN GROUP ITALIA SRL | 2021-05-05 |
| 08033178113519 | B-CAPTA | SORIN GROUP ITALIA SRL | 2021-05-05 |
| 00643169790674 | TMC50 | MEDTRONIC, INC. | 2017-02-02 |
| 00643169790698 | TMC25 | MEDTRONIC, INC. | 2017-02-02 |
| 00643169790711 | TMC38 | MEDTRONIC, INC. | 2017-02-02 |
| 00699753270114 | CDI™ H/S Cuvette 1/2 x 1/2 - Japan | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753270169 | CDI™ H/S Cuvette 1/4 x 1/4 | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753270152 | CDI™ H/S Cuvette 3/8 x 3/8 | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753270145 | CDI™ H/S Cuvette 1/2 x 1/2 | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753270138 | CDI™ H/S Cuvette 1/4 x 1/4 - Japan | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753270121 | CDI™ H/S Cuvette 3/8 x 3/8 - Japan | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753269040 | CDI™ H/S Cuvette 1/4 x 1/4 with Extension | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753269033 | CDI™ H/S Cuvette 3/8 x 3/8 with Extension | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753269026 | CDI™ H/S Cuvette 1/2 x 1/2 with Extension | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00699753160767 | CDI™ Shunt Sensor | Terumo Cardiovascular Systems Corporation | 2016-10-06 |
| 00673978538426 | NA | MEDTRONIC, INC. | 2016-09-04 |
| 00681490009829 | TMC 38 | MEDTRONIC, INC. | 2016-06-17 |
| 00681490009812 | TMC 25 | MEDTRONIC, INC. | 2016-06-17 |
| 00721902358913 | TRILLIUM™ | MEDTRONIC, INC. | 2016-06-17 |
| 00681490009836 | NA | MEDTRONIC, INC. | 2016-06-16 |
| 00721902358944 | TRILLIUM™ | MEDTRONIC, INC. | 2016-06-16 |
| 00673978538402 | NA | MEDTRONIC, INC. | 2016-06-16 |
| 00673978564210 | NA | MEDTRONIC, INC. | 2015-06-11 |
| 00673978564173 | NA | MEDTRONIC, INC. | 2015-06-11 |