Product code PTI
- Device name
- Non-Coring (Huber) Needle
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5570
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-05-13 |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 |
| K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | Bard Access Systems, Inc. | 2024-11-27 |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023-06-08 |
| K213823 | Intera Refill Kit | Intera Oncology, Inc. | 2022-03-16 |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | Intera Oncology, Inc. | 2021-10-14 |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021-04-07 |
| K170881 | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | 2017-12-14 |
| K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site | B.Braun Medical, Inc. | 2017-11-03 |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | 2017-08-08 |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | 2017-07-18 |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017-04-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04987488111304 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111311 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111328 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111335 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111342 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111359 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111366 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111373 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111380 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111397 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111403 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 04987488111298 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | SB-KAWASUMI LABORATORIES, INC. | 2026-05-31 |
| 10197344039753 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039821 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039807 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039791 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039739 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-11 |
| 10197344039814 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-09-27 |
| 10197344039777 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-07-29 |
| 10197344039760 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-05-13 |
| 08566730080023 | Infusion Safety Products, Inc. | INFUSION SAFETY PRODUCTS, INC. | 2018-07-20 |
| 08566730080016 | Infusion Safety Products, Inc. | INFUSION SAFETY PRODUCTS, INC. | 2018-07-20 |
| 00801741118050 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118272 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118289 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118401 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118609 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118692 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118784 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |
| 00801741118791 | Port Access | Bard Access Systems, Inc. | 2017-09-22 |