Last synced on 9 December 2022 at 11:04 pm

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192034
510(k) Type
Traditional
Applicant
Pathway, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/21/2020
Days to Decision
266 days
Submission Type
Summary

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192034
510(k) Type
Traditional
Applicant
Pathway, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/21/2020
Days to Decision
266 days
Submission Type
Summary