Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
FDA 510(k) K170897 · B.Braun Medical, Inc.
510(k) numberK170897
Submission
- Device name
- Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- March 27, 2017
- Decision date
- November 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PTI – Non-Coring (Huber) Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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.
Other 510(k)s with product code PTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPTI · Traditional | Sb-Kawasumi Laboratories, Inc. | 11/26/2025SE |
| K251138 | Promisemed Safety Huber NeedlesPTI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 03/14/2025SE |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle SetPTI · Traditional | Bard Access Systems, Inc. | 11/27/2024SE |
| K230715 | Promisemed Safety Huber NeedlePTI · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/08/2023SE |
| K213823 | Intera Refill KitPTI · Special | Intera Oncology, Inc. | 03/16/2022SE |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…PTI · Traditional | Intera Oncology, Inc. | 10/14/2021SE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI · Traditional | Jiangsu Caina Medical Co.,Ltd | 04/07/2021SE |
| K170881 | ISP Safety Huber Needle Infusion SetPTI · Traditional | Infusion Safety Products, Inc. | 12/14/2017SE |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTI · Special | C.R. Bard, Inc. | 08/08/2017SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254111 | Irrigation/Urology SetsLJH · Traditional | 09/10/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | 05/15/2026SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | 07/24/2025SE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | 07/31/2024SE |
| K241845 | Introcan Safety® 2 IV CatheterFOZ · Special | 07/26/2024SE |
| K241385 | Omnifix Syringe NRFitQEH · Traditional | 07/13/2024SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | 09/15/2023SE |
| K223479 | AQUAbase nXFIP · Traditional | 08/16/2023SE |
| K220756 | Introcan Safety 2 IV CatheterFOZ · Special | 06/23/2022SE |
| K220626 | Introcan Safety IV CatheterFOZ · Special | 05/14/2022SE |
Questions and answers
When was Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site cleared by the FDA?
Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (K170897) received a 510(k) decision of Substantially Equivalent on November 3, 2017, 221 days after the submission was received.
What is the product code of K170897?
The FDA product code is PTI – Non-Coring (Huber) Needle, a Class II (moderate risk) device regulated under 21 CFR 880.5570.