510(k) K171735
K171735 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set". The FDA issued a decision of Substantially Equivalent on August 8, 2017. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2017
- Date Received
- June 12, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Coring (Huber) Needle
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.