FDA.report

510(k) K241353

Device
PowerLoc? Max Power Injectable Infusion Set; SafeStep? Huber Needle Set
Applicant
Bard Access Systems, Inc.
510(k) number
K241353
Product code
PTI
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-27
Date received
2024-05-13
Regulation
880.5570
Classification name
Non-Coring (Huber) Needle
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Catherine Langford
Address
605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116

FDA Registration Numbers

Source Documents

510(k) summary PDF

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