DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Class II
FDA Device Classification
Classification Details
- Product Code
- DRY
- Device Class
- Class II
- Regulation Number
- 870.4330
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K234065 | terumo cardiovascular systems corporation | CDI OneView Monitoring System | April 25, 2024 |
| K202154 | livanova deutschland | B-Capta | April 1, 2021 |
| K202557 | spectrum medical | Quantum Workstation 12 Elite | October 2, 2020 |
| K182110 | terumo cardiovascular systems corporation | CDI Blood Parameter Monitoring System 550 | November 2, 2018 |
| K181923 | spectrum medical | Quantum Workstation 12.1 | August 17, 2018 |
| K173591 | spectrum medical | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | March 28, 2018 |
| K163657 | spectrum medical | Quantum Workstation | January 18, 2017 |
| K133157 | medtronic | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURF | October 23, 2014 |
| K133658 | terumo cardiovascular systems | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | July 25, 2014 |
| K123039 | terumo cardiovascular systems | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | November 20, 2012 |
| K110957 | spectrum medical | M4 MONITOR | May 31, 2011 |
| K103168 | sorin group deutschland | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | January 6, 2011 |
| K091908 | spectrum medical | M3 MONITOR | July 10, 2009 |
| K090147 | maquet cardiopulmonary | BLOOD MONITORING UNIT, MODEL BMU 40 | April 22, 2009 |
| K072131 | spectrum medical | M3 MONITOR | August 17, 2007 |
| K071725 | spectrum medical | M2 MONITOR | July 11, 2007 |
| K062468 | spectrum medical | SPECTRUM M2 MONITOR | September 13, 2006 |
| K012743 | medtronic perfusion systems | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | September 14, 2001 |
| K001388 | dideco | DATA MASTER PERFUSION MONITORING SYSTEM | July 28, 2000 |
| K980732 | 3m healthcare | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | May 15, 1998 |