BCD Advanced Blood Carioplegia Systems
FDA 510(k) K925369 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK925369
Submission
- Device name
- BCD Advanced Blood Carioplegia Systems
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Irvine, CA, US - Received
- October 23, 1992
- Decision date
- March 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | Spectrum Medical , Ltd. | 07/08/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special | Medtronic | 02/23/2024SE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 05/06/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 01/10/2022SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 06/19/2020SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
More from Quest Medical, Inc.
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| K931444 | Plexus 2 & 3.5 Hollow Fiber OxygenatorsDTZ · Traditional | 05/27/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | 05/18/1993SE |
| K925615 | Shiley Specialized,Pediatric & Neonatal Trach.TubeCBI · Traditional | 03/26/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | 02/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | 02/02/1993SE |
| K922933 | Sorin Monolyrh Integrated Membrane LungDTZ · Traditional | 11/30/1992SE |
| K854963 | S80 Implantable Cardiac Pacing LeadDTB · Traditional | 06/24/1986SE |
| K852641 | Orion 40 Cardiac Stimulator & PMP 200 ProgrammerDXY · Traditional | 01/14/1986SE |
| K851365 | Sorin Biomedica Orion 30/A Cardiac Stimulator & PMDXY · Traditional | 12/03/1985SE |
| K841948 | Testosterone Direct RadioimmunoassayCDZ · Traditional | 06/25/1984SE |
Questions and answers
When was BCD Advanced Blood Carioplegia Systems cleared by the FDA?
BCD Advanced Blood Carioplegia Systems (K925369) received a 510(k) decision of Substantially Equivalent on March 26, 1993, 154 days after the submission was received.
What is the product code of K925369?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.