Capiox Advance Hardshell Reservoir
FDA 510(k) K153143 · Terumo Cardiovascular Systems Corporation
510(k) numberK153143
Submission
- Device name
- Capiox Advance Hardshell Reservoir
- Applicant
- Terumo Cardiovascular Systems Corporation
Elkton, MD, US - Received
- October 30, 2015
- Decision date
- December 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
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| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | Spectrum Medical S.R.L. | 07/18/2024SE |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
| K223361 | BMR 1900 PhisioDTN · Traditional | Sorin Group Italia S.R.L. | 06/10/2023SE |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceDTN · Special | Medtronic, Inc. | 03/17/2017SE |
| K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F CDTN · Traditional | Sorin Group Italia S.R.L. | 03/08/2017SE |
| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | Maquet Cardiopulmonary, AG | 07/07/2014SE |
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
| K140321 | Initary Better Bladder-PediatricDTN · Special | Circulatory Technology, Inc. | 04/17/2014SE |
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|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | 04/25/2024SE |
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| 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 Capiox Advance Hardshell Reservoir cleared by the FDA?
Capiox Advance Hardshell Reservoir (K153143) received a 510(k) decision of Substantially Equivalent on December 2, 2015, 33 days after the submission was received.
What is the product code of K153143?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.