Device Classification Name |
heat-exchanger, cardiopulmonary bypass
|
510(k) Number |
K223879 |
Device Name |
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) |
Applicant |
Quara S.r.l. |
Via di Mezzo, 23 |
Mirandola,
IT
41037
|
|
Applicant Contact |
Raffaella Tommasini |
Correspondent |
Quara S.r.l. |
Via di Mezzo, 23 |
Mirandola,
IT
41037
|
|
Correspondent Contact |
Raffaella Tommasini |
Regulation Number | 870.4240
|
Classification Product Code |
|
Date Received | 12/27/2022 |
Decision Date | 04/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|