Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model(S) CHX30, Bsq-Chx 30
FDA 510(k) K072583 · Maquet Cardiopulmonary, AG
510(k) numberK072583
Submission
- Device name
- Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model(S) CHX30, Bsq-Chx 30
- Applicant
- Maquet Cardiopulmonary, AG
Hirrlingen, DE - Received
- September 13, 2007
- Decision date
- April 4, 2008
- 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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| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
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| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
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| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
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Questions and answers
When was Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model(S) CHX30, Bsq-Chx 30 cleared by the FDA?
Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model(S) CHX30, Bsq-Chx 30 (K072583) received a 510(k) decision of Substantially Equivalent on April 4, 2008, 204 days after the submission was received.
What is the product code of K072583?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.