FDA.report

510(k) K252541

Device
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
Applicant
Spectrum Medical S.R.L.
510(k) number
K252541
Product code
DTR
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-12
Date received
2025-08-12
Regulation
870.4240
Classification name
Heat-Exchanger, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Raffaella Tommasini
Address
Via Di Mezzo, 23 Mirandola IT 41037 41037

FDA Registration Numbers

Source Documents

510(k) summary PDF

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