ATR-2900DF (with Depth FILTER)/CAP-35DF (with Depth Filter)
FDA 510(k) K936286 · Gish Biomedical, Inc.
510(k) numberK936286
Submission
- Device name
- ATR-2900DF (with Depth FILTER)/CAP-35DF (with Depth Filter)
- Applicant
- Gish Biomedical, Inc.
Irvine, CA, US - Received
- November 30, 1993
- Decision date
- February 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTDTZ · Traditional | 09/18/2009SE |
| K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LTDTZ · Traditional | 09/18/2009SE |
| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730DTN · Traditional | 08/04/2009SE |
| K083131 | Medos Hilite Reservoir, Model: 4030DTN · Traditional | 07/30/2009SE |
| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LTDTZ · Traditional | 05/15/2009SE |
| K082082 | Gish SVR Soft Venous Reservoirs with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
| K081838 | Gish Vision Blood Cardioplegia with Ha CoatingDTR · Traditional | 01/26/2009SE |
| K081881 | Gish Tubing and Connectors with Ha CoatingDWF · Traditional | 01/23/2009SE |
Questions and answers
When was ATR-2900DF (with Depth FILTER)/CAP-35DF (with Depth Filter) cleared by the FDA?
ATR-2900DF (with Depth FILTER)/CAP-35DF (with Depth Filter) (K936286) received a 510(k) decision of Substantially Equivalent on February 14, 1994, 76 days after the submission was received.
What is the product code of K936286?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.