Last synced on 27 June 2025 at 11:06 pm

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241353
510(k) Type
Traditional
Applicant
Bard Access Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/27/2024
Days to Decision
198 days
Submission Type
Summary

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241353
510(k) Type
Traditional
Applicant
Bard Access Systems, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/27/2024
Days to Decision
198 days
Submission Type
Summary