DTN — Reservoir, Blood, Cardiopulmonary Bypass Class II
FDA product code DTN covers "Reservoir, Blood, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4400. 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
- 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 |