PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set— 510(k) K241353
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K241353 for PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set, Substantially Equivalent on 2024-11-27. Applicant: Bard Access Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, Inc.
- Product code
- Code PTI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake Ciy,, UT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.