510(k) K223879 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
| Applicant | Quara S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Apr 13, 2023 |
| Received | Dec 27, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223879
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | SPECTRUM MEDICAL SRL Brand Name: Quantum PureFlow
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
Model/Catalog Number: HX55V-S0W
Software Version: N/A
Product Description: The Quantum PureFlow Stan Open, Classified |
DTR | None listed |
| Sep 29, 2026 | SPECTRUM MEDICAL SRL Brand Name: Quantum PureFlow
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8
Model/Catalog Number: HX55W-S0
Software Version: N/A
Product Description: The Quantum PureFlow Standar Open, Classified |
DTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.