DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Class II
FDA product code DRY covers "Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4330. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |