The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Power-injectable Implantable Ports (powerports®).
| Device ID | K181446 |
| 510k Number | K181446 |
| Device Name: | Bard Power-Injectable Implantable Ports (PowerPorts®) |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Jeff Peterson |
| Correspondent | Jeff Peterson C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2019-07-08 |