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Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153226
510(k) Type
Traditional
Applicant
ZOLL CIRCULATION, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/24/2016
Days to Decision
139 days
Submission Type
Summary

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153226
510(k) Type
Traditional
Applicant
ZOLL CIRCULATION, INC.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
3/24/2016
Days to Decision
139 days
Submission Type
Summary