Norton Cardioplegic Quick Cooling Coil 421738-000
FDA 510(k) K853791 · Norton Performance Plastics Corp.
510(k) numberK853791
Submission
- Device name
- Norton Cardioplegic Quick Cooling Coil 421738-000
- Applicant
- Norton Performance Plastics Corp.
Akron, OH, US - Received
- September 11, 1985
- Decision date
- December 9, 1985
- 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 |
|---|---|---|
| K852914 | Angiographic, Wedge Press, Dual Thermod & InfusionDQY · Traditional | 09/25/1985SE |
| K851299 | Correct FloFPA · Traditional | 05/07/1985SE |
| K842858 | Fluid Administration Line W/Spike 14-923FPA · Traditional | 09/11/1984SE |
| K841828 | Central Venous Catheter W/Big-GardDQY · Traditional | 07/13/1984SE |
| K840240 | Microfuse Intravenous Catheter SetDQY · Traditional | 04/17/1984SE |
| K831587 | Temp. Repair Kit-Dual Lumen CatheterLJS · Traditional | 10/19/1983SE |
| K831698 | Disposable Pressure TRANSDUCER#14004195DRS · Traditional | 08/11/1983SE |
| K830788 | Central Vein Catherization KIT-14-690-DQO · Traditional | 04/30/1983SE |
| K830813 | French Percutaneous Sheath IntroducerDYB · Traditional | 04/28/1983SE |
| K830969 | Perm. Repair Kit for Leonard Norton DualLJS · Traditional | 04/14/1983SE |
Questions and answers
When was Norton Cardioplegic Quick Cooling Coil 421738-000 cleared by the FDA?
Norton Cardioplegic Quick Cooling Coil 421738-000 (K853791) received a 510(k) decision of Substantially Equivalent on December 9, 1985, 89 days after the submission was received.
What is the product code of K853791?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.