FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
K Number: K241353
·
Decision Nov 27, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
21
Review Days
198
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Basic Information
- Device Name
- PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- K Number
- K241353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Access Systems, Inc.
- Date Received
- May 13, 2024
- Decision Date
- November 27, 2024
- Product Code
- PTI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PTI | Non-Coring (Huber) Needle | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PTI), ordered by most recent decision date.
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FDA 510(k)
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FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Bard Access Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Sep 5, 2025 | Substantially Equivalent |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Jun 18, 2025 | Substantially Equivalent |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Oct 31, 2024 | Substantially Equivalent |
| K240146 | BD Prevue II Peripheral Vascular Access System | Feb 18, 2024 | Substantially Equivalent |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Aug 24, 2022 | Substantially Equivalent |
| K210264 | BD PowerPiCC Catheter | Jul 30, 2021 | Substantially Equivalent |
| K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | May 30, 2012 | Substantially Equivalent |
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | May 18, 2007 | Substantially Equivalent |
| K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING | Apr 13, 2006 | Substantially Equivalent |