EL2-SERIES Blood Collection Reervoir
FDA 510(k) K930154 · Electromedics, Inc.
510(k) numberK930154
Submission
- Device name
- EL2-SERIES Blood Collection Reervoir
- Applicant
- Electromedics, Inc.
Englewood, CO, US - Received
- January 13, 1993
- Decision date
- July 1, 1993
- 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 |
|---|---|---|
| K073616 | Fas-Clean Electrosurgical Coated Active BladeGEI · Traditional | 07/23/2008SE |
| K934964 | Electromedics Tympanic Temperature SensorFLL · Traditional | 03/07/1994SE |
| K933832 | Electromedics HG (Hydrogel) Series Skin Temperature SensorFLL · Traditional | 01/28/1994SE |
| K934355 | Electromedics Blood Heat ExchangerDTR · Traditional | 12/03/1993SE |
| K926250 | Electromedics El-Series Cardiotomy ReservoirDTN · Traditional | 02/19/1993SE |
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | 02/05/1993SE |
| K915737 | Autotransfusion Blood Collection ReservoirDTN · Traditional | 09/03/1992SE |
| K910238 | Portable Auto Transfusion System 500CAC · Traditional | 06/19/1991SE |
| K910935 | Modified Pyrogen TestingDTM · Traditional | 05/16/1991SE |
| K902723 | Arterial Blood Filter Electro. Air* Star 40 and 20DTM · Traditional | 12/13/1990SE |
Questions and answers
When was EL2-SERIES Blood Collection Reervoir cleared by the FDA?
EL2-SERIES Blood Collection Reervoir (K930154) received a 510(k) decision of Substantially Equivalent on July 1, 1993, 169 days after the submission was received.
What is the product code of K930154?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.