DTN · Reservoir, Blood, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4400 · Class 2
Overview
| Product Code | DTN |
|---|---|
| Device Name | Reservoir, Blood, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4400 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.
Classification Rationale
Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 169)
Showing 20 most recent of 169 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | Dec 22, 2025 | SESE |
| K241206 | Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. | Jul 18, 2024 | SESE |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL | Medtronic Cardiac Surgery | May 15, 2024 | SESE |
| K223361 | BMR 1900 PHISIO | Sorin Group Italia S.R.L. | Jun 10, 2023 | SESE |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | Medtronic, Inc. | Mar 17, 2017 | SESE |
| K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | Sorin Group Italia S.R.L. | Mar 8, 2017 | SESE |
| K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | Dec 2, 2015 | SESE |
| K151110 | Intersept Filtered Cardiotomy Reservoir | Medtronic, Inc. | May 27, 2015 | SESE |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | Maquet Cardiopulmonary, AG | Jul 7, 2014 | SESE |
| K141233 | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | Medtronic, Inc. | Jun 12, 2014 | SESE |
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | Circulatory Technology, Inc. | Apr 17, 2014 | SESE |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | Maquet Cardiopulmonary, AG | Oct 30, 2013 | SESE |
| K132972 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | Medtronic, Inc. | Oct 28, 2013 | SESE |
| K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | Jun 6, 2013 | SESE |
| K122914 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE | Medtronic, Inc. | Jan 9, 2013 | SESE |
| K112771 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | Sorin Group Italia S.R.L. | Oct 14, 2011 | SESE |
| K102919 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE | Maquet Cardiopulmonary, AG | Mar 11, 2011 | SESE |
| K100507 | XRES BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | Mar 24, 2010 | SESE |
| K090690 | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | Dec 23, 2009 | SESE |
| K090534 | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | Maquet Cardiopulmonary, AG | Dec 23, 2009 | SESE |
Top Applicants
- Gish Biomedical, Inc. — 16 clearances
- Shiley, Inc. — 14 clearances
- American Bentley — 11 clearances
- C.R. Bard, Inc. — 10 clearances
- Cobe Cardiovascular, Inc. — 9 clearances
