Cardioplegia Heat Exchanger HE-100
FDA 510(k) K840045 · American Bentley
510(k) numberK840045
Submission
- Device name
- Cardioplegia Heat Exchanger HE-100
- Applicant
- American Bentley
Walker, MI, US - Received
- January 6, 1984
- Decision date
- February 13, 1984
- 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
| 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 |
|---|---|---|
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | 02/12/1988SE |
| K873923 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 11/06/1987SE |
| K872167 | Cardiotomy/Mediastinal Auto. Reservoir CATR-3500DTP · Traditional | 09/01/1987SE |
| K870804 | Cardioplegia Heat Exchanger Model No. HE-100DTR · Traditional | 09/01/1987SE |
| K872133 | Oxygenator Model No. Bentley 5 PlusDTZ · Traditional | 08/24/1987SE |
| K870911 | Indwelling Blood Carbondioxide Partial Pres. AnalyCCC · Traditional | 05/29/1987SE |
| K870269 | Electrosurgical Meniscus Cutter (Emc) Mod. AMC-100GEI · Traditional | 03/09/1987SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | 09/29/1986SE |
| K862549 | Arterial Blood Filter Holder Model No. Af-HeKRI · Traditional | 07/15/1986SE |
Questions and answers
When was Cardioplegia Heat Exchanger HE-100 cleared by the FDA?
Cardioplegia Heat Exchanger HE-100 (K840045) received a 510(k) decision of Substantially Equivalent on February 13, 1984, 38 days after the submission was received.
What is the product code of K840045?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.