FDA Product Code
FDA Product Code PTI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5570
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254095 | 25G Huber Needle | Martech Medical Products | 2026-09-18 | Traditional | PDF ↗ |
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 | Traditional | PDF ↗ |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-05-13 | Special | PDF ↗ |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 | Special | PDF ↗ |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | Bard Access Systems, Inc. | 2024-11-27 | Traditional | PDF ↗ |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023-06-08 | Traditional | PDF ↗ |
| K213823 | Intera Refill Kit | Intera Oncology, Inc. | 2022-03-16 | Special | PDF ↗ |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | Intera Oncology, Inc. | 2021-10-14 | Traditional | PDF ↗ |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021-04-07 | Traditional | PDF ↗ |
| K170881 | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | 2017-12-14 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | 2017-08-08 | Special | PDF ↗ |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | 2017-07-18 | Special | PDF ↗ |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017-04-26 | Traditional | PDF ↗ |
Product code PTI · Class II · General Hospital. Data: openFDA.