FDA Product Code
FDA Product Code DRY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4330
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024-04-25 | Traditional | PDF ↗ |
| K202154 | B-Capta | Livanova Deutschland, GmbH | 2021-04-01 | Traditional | PDF ↗ |
| K202557 | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | 2020-10-02 | Special | PDF ↗ |
| K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018-11-02 | Traditional | PDF ↗ |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | 2018-08-17 | Special | PDF ↗ |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical , Ltd. | 2018-03-28 | Traditional | PDF ↗ |
| K163657 | Quantum Workstation | Spectrum Medical , Ltd. | 2017-01-18 | Special | PDF ↗ |
| K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | Medtronic, Inc. | 2014-10-23 | Traditional | PDF ↗ |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2014-07-25 | Traditional | PDF ↗ |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2012-11-20 | Traditional | PDF ↗ |
| K110957 | M4 MONITOR | Spectrum Medical, Llp | 2011-05-31 | Traditional | PDF ↗ |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | Sorin Group Deutschland GmbH | 2011-01-06 | Traditional | PDF ↗ |
| K091908 | M3 MONITOR | Spectrum Medical , Ltd. | 2009-07-10 | Traditional | PDF ↗ |
| K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 | Maquet Cardiopulmonary, AG | 2009-04-22 | Traditional | PDF ↗ |
| K072131 | M3 MONITOR | Spectrum Medical , Ltd. | 2007-08-17 | Traditional | PDF ↗ |
| K071725 | M2 MONITOR | Spectrum Medical , Ltd. | 2007-07-11 | Traditional | PDF ↗ |
| K062468 | SPECTRUM M2 MONITOR | Spectrum Medical, Llp | 2006-09-13 | Traditional | PDF ↗ |
| K012743 | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | Medtronic Perfusion Systems | 2001-09-14 | Special | PDF ↗ |
| K001388 | DATA MASTER PERFUSION MONITORING SYSTEM | Dideco | 2000-07-28 | Abbreviated | PDF ↗ |
| K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | 3M Healthcare | 1998-05-15 | Traditional | PDF ↗ |
| K973472 | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT | 3M Healthcare | 1997-12-08 | Traditional | PDF ↗ |
| K972962 | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 | 3M Company | 1997-11-06 | Traditional | PDF ↗ |
| K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | International Biophysics Corp. | 1996-05-14 | Traditional | PDF ↗ |
| K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | International Biophysics Corp. | 1996-05-14 | Traditional | PDF ↗ |
| K941922 | MEDSAT OXYGEN SATURATION SYSTEM | Medtronic Bio-Medicus, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | 3M Health Care, Ltd. | 1993-11-10 | Traditional | PDF ↗ |
| K915265 | CDI(TM) H/S CUVETTE, MODIFICATION | 3M Company | 1992-01-15 | Traditional | PDF ↗ |
| K915255 | CDI(TM) 300, 400 & 100, MODIFICATION | 3M Company | 1992-01-15 | Traditional | PDF ↗ |
| K910421 | SATURATION/HEMATOCRIT MONITOR SYSTEM | Medtronic Vascular | 1991-10-15 | Traditional | PDF ↗ |
| K903729 | GOLD GATORS | Lead-Lok, Inc. | 1990-09-14 | Traditional | PDF ↗ |
| K900682 | PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE | Contour Electrodes, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K900459 | APPLICARD (EKG) | Medi-Globe Corp. | 1990-07-31 | Traditional | PDF ↗ |
| K881006 | STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 | Shiley, Inc. | 1988-05-24 | Traditional | PDF ↗ |
| K874839 | STAT-SAT | Gish Biomedical, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K871686 | GEM-CRIT CHECK | Diamond Sensor Systems | 1987-06-18 | Traditional | PDF ↗ |
| K871221 | CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 | Cardiovascular Devices, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K862953 | CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE | Classic Medical Products, Inc. | 1986-08-25 | Traditional | PDF ↗ |
| K862069 | CARDIOMET 4000 GAS MONITORING SYSTEMS | Biomedical Sensors, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K861277 | CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 | Critichem, Inc. | 1986-06-02 | Traditional | PDF ↗ |
| K854357 | GEM-6, WITH COMPONENTS | Diamond Electro-Tech, Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K852124 | HEMATOCRIT-SATURATION MONITOR HSM-100 | American Bentley | 1985-09-16 | Traditional | PDF ↗ |
| K843709 | COBE SATURATION CELL | Cobe Laboratories, Inc. | 1984-10-24 | Traditional | PDF ↗ |
| K843538 | PO 2 LYTRODE | Polystan C/O Vitalcor, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K831225 | GAS-STAT MONITORING SYSTEM | Cardiovascular Devices, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Bentley Laboratories, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K821159 | IN-LINE OXYGEN MONITORING SYSTEM | G.D. Searle and Co. | 1982-05-25 | Traditional | PDF ↗ |
| K811391 | OXIMETRIX ACCU SAT CPB | Oximetrix, Inc. | 1981-07-20 | Traditional | PDF ↗ |
Product code DRY · Class II · Cardiovascular. Data: openFDA.