The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerflow Implantable Apheresis Iv Port.
| Device ID | K191143 |
| 510k Number | K191143 |
| Device Name: | PowerFlow Implantable Apheresis IV Port |
| Classification | Subcutaneous Implanted Apheresis Port |
| Applicant | C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Kristen Soodak |
| Correspondent | Kristen Soodak C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | PTD |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-30 |
| Decision Date | 2019-08-02 |