FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
K Number: K171735
·
Decision Aug 8, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
645
Review Days
57
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Basic Information
- Device Name
- PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
- K Number
- K171735
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- June 12, 2017
- Decision Date
- August 8, 2017
- 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 Class 2
·General Hospital
PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
FDA 510(k)
FDA Class 2
·General Hospital
Promisemed Safety Huber Needle
FDA 510(k)
FDA Class 2
·General Hospital
Intera Refill Kit
FDA 510(k)
FDA Class 2
·General Hospital
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