Cdi Blood Parameter Monitoring System 500
FDA 510(k) K133658 · Terumo Cardiovascular Systems Corp.
510(k) numberK133658
Submission
- Device name
- Cdi Blood Parameter Monitoring System 500
- Applicant
- Terumo Cardiovascular Systems Corp.
Ann Arbor, MI, US - Received
- November 27, 2013
- Decision date
- July 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
Other 510(k)s with product code DRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | Terumo Cardiovascular Systems Corporation | 04/25/2024SE |
| K202154 | B-CaptaDRY · Traditional | Livanova Deutschland, GmbH | 04/01/2021SE |
| K202557 | Quantum Workstation 12 EliteDRY · Special | Spectrum Medical , Ltd. | 10/02/2020SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | Terumo Cardiovascular Systems Corporation | 11/02/2018SE |
| K181923 | Quantum Workstation 12.1DRY · Special | Spectrum Medical , Ltd. | 08/17/2018SE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY · Traditional | Spectrum Medical , Ltd. | 03/28/2018SE |
| K163657 | Quantum WorkstationDRY · Special | Spectrum Medical , Ltd. | 01/18/2017SE |
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…DRY · Traditional | Medtronic, Inc. | 10/23/2014SE |
| K123039 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 11/20/2012SE |
| K110957 | M4 MonitorDRY · Traditional | Spectrum Medical, Llp | 05/31/2011SE |
More from Spectrum Medical, Llp
| 510(k) | Device | Decision |
|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | 04/25/2024SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | 04/18/2023SE |
| K200091 | Capiox iCP Centrifugal PumpKFM · Traditional | 11/18/2021SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | 11/02/2018SE |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…DTZ · Traditional | 06/22/2018SE |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…DTZ · Traditional | 03/29/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | 06/07/2017SE |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | 11/17/2016SE |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/21/2016SE |
Questions and answers
When was Cdi Blood Parameter Monitoring System 500 cleared by the FDA?
Cdi Blood Parameter Monitoring System 500 (K133658) received a 510(k) decision of Substantially Equivalent on July 25, 2014, 240 days after the submission was received.
What is the product code of K133658?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.