Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System
FDA 510(k) K021830 · Cobe Cardiovascular, Inc.
510(k) numberK021830
Submission
- Device name
- Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- June 4, 2002
- Decision date
- July 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
| 510(k) | Device | Decision |
|---|---|---|
| K050111 | Smarxt BMR 1900 Closed Venous Reservoir BagDTN · Abbreviated | 03/08/2005SE |
| K042473 | Cobe Angel Whole Blood Separation SystemJQC · Abbreviated | 11/19/2004SE |
| K040184 | Dideco Micro 40 Ph.I.S.I.O. Adult Arterial FilterDTM · Special | 02/26/2004SE |
| K033641 | Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800DTN · Special | 12/11/2003SE |
| K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700KFM · Special | 03/06/2003SE |
| K011835 | Cobe RevolutionKFM · Abbreviated | 02/12/2002SE |
| K013480 | Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorDTZ · Special | 11/16/2001SE |
| K012763 | Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia SystemDRT · Abbreviated | 11/15/2001SE |
| K001509 | Stockert V172 Series Venous Femoral CannulaeDWF · Abbreviated | 10/26/2001SE |
| K012898 | Modification to: CSC14 Blood Cardioplegia SystemDTR · Special | 09/17/2001SE |
Questions and answers
When was Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System cleared by the FDA?
Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System (K021830) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 28 days after the submission was received.
What is the product code of K021830?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.