The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerflow Apheresis I.v. Port.
| Device ID | K163001 |
| 510k Number | K163001 |
| Device Name: | PowerFlow Apheresis I.V. Port |
| Classification | Subcutaneous Implanted Apheresis Port |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Christoph Wagner Von Hoff |
| Correspondent | Christoph Wagner Von Hoff 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 | 2016-10-28 |
| Decision Date | 2017-04-17 |
| Summary: | summary |