Heat Exchanger, FHX-14
FDA 510(k) K781210 · Delta Medical Industries
510(k) numberK781210
Submission
- Device name
- Heat Exchanger, FHX-14
- Applicant
- Delta Medical Industries
Mchenry, IL, US - Received
- July 17, 1978
- Decision date
- October 10, 1978
- 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 |
|---|---|---|
| K833884 | Isotec Dispos. Pressure Transducer · Traditional | 04/17/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | 04/05/1984SE |
| K832470 | Infusion PumpFRN · Traditional | 02/28/1984SE |
| K830389 | Accu-Rynge Pump SP-250FRN · Traditional | 09/12/1983SE |
| K831750 | PM-3DXS · Traditional | 07/26/1983SE |
| K822761 | Delivery Tube Set #2226FRN · Traditional | 09/30/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | 05/18/1982SE |
| K820482 | Accu-Rynge Insulin Pump #SP-250FRN · Traditional | 03/26/1982SE |
| K810068 | Pediatric Arterial Blood FilterDTM · Traditional | 01/22/1981SE |
| K802755 | Arterial Blood Filter BF-37DTM · Traditional | 01/07/1981SE |
Questions and answers
When was Heat Exchanger, FHX-14 cleared by the FDA?
Heat Exchanger, FHX-14 (K781210) received a 510(k) decision of Substantially Equivalent on October 10, 1978, 85 days after the submission was received.
What is the product code of K781210?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.