DTN — Reservoir, Blood, Cardiopulmonary Bypass Class II
FDA Device Classification
Classification Details
- Product Code
- DTN
- Device Class
- Class II
- Regulation Number
- 870.4400
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251783 | sorin group italia | Inspire HCR and HCR DUAL cardiotomy reservoirs | December 22, 2025 |
| K241206 | spectrum medical | Quantum Perfusion Hybrid System | July 18, 2024 |
| K241053 | medtronic cardiac surgery | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous | May 15, 2024 |
| K223361 | sorin group italia | BMR 1900 PHISIO | June 10, 2023 |
| K170583 | medtronic | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | March 17, 2017 |
| K161733 | sorin group italia | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | March 8, 2017 |
| K153143 | terumo cardiovascular systems corporation | Capiox Advance Hardshell Reservoir | December 2, 2015 |
| K151110 | medtronic | Intersept Filtered Cardiotomy Reservoir | May 27, 2015 |
| K141432 | maquet cardiopulmonary | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI | July 7, 2014 |
| K141233 | medtronic | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU | June 12, 2014 |
| K140321 | circulatory technology | INITARY BETTER BLADDER-PEDIATRIC | April 17, 2014 |
| K132166 | maquet cardiopulmonary | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH | October 30, 2013 |
| K132972 | medtronic | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | October 28, 2013 |
| K131103 | sorin group italia | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | June 6, 2013 |
| K122914 | medtronic | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, | January 9, 2013 |
| K112771 | sorin group italia | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | October 14, 2011 |
| K102919 | maquet cardiopulmonary | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSI | March 11, 2011 |
| K100507 | sorin group italia | XRES BLOOD COLLECTION RESERVOIR | March 24, 2010 |
| K090690 | maquet cardiopulmonary | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | December 23, 2009 |
| K090534 | maquet cardiopulmonary | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | December 23, 2009 |