The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerport Implanted Port With Groshong Catheter.
| Device ID | K081311 |
| 510k Number | K081311 |
| Device Name: | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Jihyun Kim |
| Correspondent | Jihyun Kim 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-09 |
| Decision Date | 2008-06-04 |
| Summary: | summary |