510(k) K102919
- Device
- NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
- Applicant
- MAQUET CARDIOPULMONARY AG
- 510(k) number
- K102919
- Product code
- DTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-11
- Date received
- 2010-10-01
- Regulation
- 870.4400
- Classification name
- Reservoir, Blood, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATRIN SCHWENKGLENKS
- Address
- Hechinger Strasse 38 Hirrlingen DE 72145 72145
FDA Registration Numbers#
- 3004080795
- 9617601
- 2029275
- 3004548776
- 9681834
- 3016746283
- 3008307705
- 3002806603
- 3019807891
- 1625519
- 3011554160
- 9612051
- 3003752502
- 2184009
- 1724474
- 1643817
- 1047843
- 3005941719
- 3003661577
- 2011171
- 3009746061
- 1124841
- 1319639
- 3030125051
- 9680841
- 8010026
- 1928237
- 3007829657
- 1718850
Source Documents#
Other 510(k) Records For Product Code DTN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | 2025-12-22 |
| K241206 | Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. | 2024-07-18 |
| 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 | 2024-05-15 |
| K223361 | BMR 1900 PHISIO | Sorin Group Italia S.R.L. | 2023-06-10 |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | Medtronic, Inc. | 2017-03-17 |
| K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | Sorin Group Italia S.R.L. | 2017-03-08 |
| K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-12-02 |
| K151110 | Intersept Filtered Cardiotomy Reservoir | Medtronic, Inc. | 2015-05-27 |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | Maquet Cardiopulmonary, AG | 2014-07-07 |
| K141233 | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | Medtronic, Inc. | 2014-06-12 |
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | Circulatory Technology, Inc. | 2014-04-17 |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | Maquet Cardiopulmonary, AG | 2013-10-30 |
| K132972 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2013-10-28 |
| K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | 2013-06-06 |
| K122914 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE | Medtronic, Inc. | 2013-01-09 |
Legacy Summary#
summary
FDA Review#
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