The V-Bag
FDA 510(k) K001822 · Circulatory Technology, Inc.
510(k) numberK001822
Submission
- Device name
- The V-Bag
- Applicant
- Circulatory Technology, Inc.
Oyster Bay, NY, US - Received
- June 16, 2000
- Decision date
- July 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code DTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | Sorin Group Italia S.R.L. | 12/22/2025SE |
| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | Spectrum Medical S.R.L. | 07/18/2024SE |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
| K223361 | BMR 1900 PhisioDTN · Traditional | Sorin Group Italia S.R.L. | 06/10/2023SE |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceDTN · Special | Medtronic, Inc. | 03/17/2017SE |
| K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F CDTN · Traditional | Sorin Group Italia S.R.L. | 03/08/2017SE |
| K153143 | Capiox Advance Hardshell ReservoirDTN · Special | Terumo Cardiovascular Systems Corporation | 12/02/2015SE |
| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | Maquet Cardiopulmonary, AG | 07/07/2014SE |
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K140321 | Initary Better Bladder-PediatricDTN · Special | 04/17/2014SE |
| K012942 | The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog…DTN · Traditional | 11/05/2001SE |
| K981284 | Better-Bladder (BB)DTN · Traditional | 08/12/1998SE |
| K964205 | Better-TubingDWF · Traditional | 04/08/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | 05/23/1997SE |
| K961594 | Better-VenterDWF · Traditional | 09/05/1996SE |
| K941492 | Pressure Relief ValveMNJ · Traditional | 10/26/1994SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | 08/25/1994SE |
Questions and answers
When was The V-Bag cleared by the FDA?
The V-Bag (K001822) received a 510(k) decision of Substantially Equivalent on July 7, 2000, 21 days after the submission was received.
What is the product code of K001822?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.