FDA.reportPublic FDA data

510(k) K223879

Device
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Applicant
Quara S.R.L.
510(k) number
K223879
Product code
DTR
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-13
Date received
2022-12-27
Regulation
870.4240
Classification name
Heat-Exchanger, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

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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510(k), Device, Applicant table
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