Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K203424 |
Device Name |
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 |
Applicant |
Qura S.r.l. |
Via di Mezzo, 23 |
Mirandola,
IT
41037
|
|
Applicant Contact |
Raffaella Tommasini |
Correspondent |
Qura S.r.l. |
Via di Mezzo, 23 |
Mirandola,
IT
41037
|
|
Correspondent Contact |
Raffaella Tommasini |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 11/20/2020 |
Decision Date | 12/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|