Cardioplegia Cooling Syst. CCAS-2
FDA 510(k) K802848 · Bentley Laboratories, Inc.
510(k) numberK802848
Submission
- Device name
- Cardioplegia Cooling Syst. CCAS-2
- Applicant
- Bentley Laboratories, Inc.
Mchenry, IL, US - Received
- November 12, 1980
- Decision date
- December 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K931967 | HE-30 GoldDTR · Traditional | 07/13/1993SE |
| K913956 | Blood Cardioplegia Heat Exchanger, Model #HE-30DTN · Traditional | 01/17/1992SE |
| K913692 | Venous Reservoir Bag Model No. BMR-250(TM)DTN · Traditional | 11/15/1991SE |
| K903641 | Quick Prime Hemoconcen. No. HQ-7000 and CBP-7000QKDI · Traditional | 11/09/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | 02/28/1990SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | 02/02/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 02/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | 01/19/1988SE |
| K823359 | Oxygen Consumption Monitor #OCM-0100DRY · Traditional | 01/05/1983SE |
| K823273 | BOS-2S, Spiraflo Bubble Infant Oxygen.DTZ · Traditional | 01/05/1983SE |
Questions and answers
When was Cardioplegia Cooling Syst. CCAS-2 cleared by the FDA?
Cardioplegia Cooling Syst. CCAS-2 (K802848) received a 510(k) decision of Substantially Equivalent on December 11, 1980, 29 days after the submission was received.
What is the product code of K802848?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.