Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating
FDA 510(k) K040355 · Gish Biomedical, Inc.
510(k) numberK040355
Submission
- Device name
- Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating
- Applicant
- Gish Biomedical, Inc.
Houston, TX, US - Received
- February 12, 2004
- Decision date
- March 15, 2004
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| 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 Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating cleared by the FDA?
Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating (K040355) received a 510(k) decision of Substantially Equivalent on March 15, 2004, 32 days after the submission was received.
What is the product code of K040355?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.