Enguard PHX Cardioplegia Heat Exchanger
FDA 510(k) K991137 · Minntech Corp.
510(k) numberK991137
Submission
- Device name
- Enguard PHX Cardioplegia Heat Exchanger
- Applicant
- Minntech Corp.
Minneapolis, MN, US - Received
- April 5, 1999
- Decision date
- June 8, 2000
- 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
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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 |
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| K000028 | Renaflo II HF 2000 HemofilterKDI · Traditional | 04/04/2000SE |
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Questions and answers
When was Enguard PHX Cardioplegia Heat Exchanger cleared by the FDA?
Enguard PHX Cardioplegia Heat Exchanger (K991137) received a 510(k) decision of Substantially Equivalent on June 8, 2000, 430 days after the submission was received.
What is the product code of K991137?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.