SAFE-1 Venous Reservoir
FDA 510(k) K893705 · Polystan C/O Vitalcor, Inc.
510(k) numberK893705
Submission
- Device name
- SAFE-1 Venous Reservoir
- Applicant
- Polystan C/O Vitalcor, Inc.
Denmark, DK - Received
- May 18, 1989
- Decision date
- December 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K894657 | Polystan Heart-Lung Machine SystemDJQ · Traditional | 03/28/1990SE |
| K893940 | Polystan Heater-Cooler UnitDWC · Traditional | 01/18/1990SE |
| K893704 | SAFE-1DTZ · Traditional | 12/22/1989SE |
| K874853 | Polystan Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K874852 | Polystan Wire Reinforced Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K872182 | Polystan Wire Reinforced Catheters and CannulaeDQY · Traditional | 10/30/1987SE |
| K843538 | Po 2 LytrodeDRY · Traditional | 10/18/1984SE |
Questions and answers
When was SAFE-1 Venous Reservoir cleared by the FDA?
SAFE-1 Venous Reservoir (K893705) received a 510(k) decision of Substantially Equivalent on December 22, 1989, 218 days after the submission was received.
What is the product code of K893705?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.