The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Bardport Titanium Ports.
| Device ID | K050310 |
| 510k Number | K050310 |
| Device Name: | BARDPORT TITANIUM PORTS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. 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 | 2005-02-08 |
| Decision Date | 2005-04-18 |
| Summary: | summary |