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Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221020
510(k) Type
Traditional
Applicant
Potrero Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
1/13/2023
Days to Decision
282 days
Submission Type
Summary

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221020
510(k) Type
Traditional
Applicant
Potrero Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
1/13/2023
Days to Decision
282 days
Submission Type
Summary