510(k) K170897
K170897 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site". The FDA issued a decision of Substantially Equivalent on November 3, 2017. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2017
- Date Received
- March 27, 2017
- Clearance Type
- Traditional
- 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.