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Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213540
510(k) Type
Traditional
Applicant
Qura S.r.l.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
5/20/2022
Days to Decision
193 days
Submission Type
Summary

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213540
510(k) Type
Traditional
Applicant
Qura S.r.l.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
5/20/2022
Days to Decision
193 days
Submission Type
Summary