Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4400](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4400) → DTN — Reservoir, Blood, Cardiopulmonary Bypass # DTN · Reservoir, Blood, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN ## Overview - **Product Code:** DTN - **Device Name:** Reservoir, Blood, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4400](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4400) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K251783.md) | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | Dec 22, 2025 | SESE | | [K241206](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K241206.md) | Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. | Jul 18, 2024 | SESE | | [K241053](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K241053.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K223361.md) | BMR 1900 PHISIO | Sorin Group Italia S.R.L. | Jun 10, 2023 | SESE | | [K170583](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K170583.md) | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | Medtronic, Inc. | Mar 17, 2017 | SESE | | [K161733](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K161733.md) | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | Sorin Group Italia S.R.L. | Mar 8, 2017 | SESE | | [K153143](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K153143.md) | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | Dec 2, 2015 | SESE | | [K151110](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K151110.md) | Intersept Filtered Cardiotomy Reservoir | Medtronic, Inc. | May 27, 2015 | SESE | | [K141432](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K141432.md) | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | Maquet Cardiopulmonary, AG | Jul 7, 2014 | SESE | | [K141233](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K141233.md) | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | Medtronic, Inc. | Jun 12, 2014 | SESE | | [K140321](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K140321.md) | INITARY BETTER BLADDER-PEDIATRIC | Circulatory Technology, Inc. | Apr 17, 2014 | SESE | | [K132166](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K132166.md) | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | Maquet Cardiopulmonary, AG | Oct 30, 2013 | SESE | | [K132972](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K132972.md) | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | Medtronic, Inc. | Oct 28, 2013 | SESE | | [K131103](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K131103.md) | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | Jun 6, 2013 | SESE | | [K122914](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K122914.md) | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE | Medtronic, Inc. | Jan 9, 2013 | SESE | | [K112771](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K112771.md) | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | Sorin Group Italia S.R.L. | Oct 14, 2011 | SESE | | [K102919](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K102919.md) | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE | Maquet Cardiopulmonary, AG | Mar 11, 2011 | SESE | | [K100507](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K100507.md) | XRES BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | Mar 24, 2010 | SESE | | [K090690](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K090690.md) | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | Dec 23, 2009 | SESE | | [K090534](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K090534.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com