The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Modification To X-port Duo Port.
| Device ID | K034065 |
| 510k Number | K034065 |
| Device Name: | MODIFICATION TO X-PORT DUO PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Angela Brady |
| Correspondent | Angela Brady C.R. BARD, INC. 5425 WEST AMELIA EARHART 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 | 2003-12-29 |
| Decision Date | 2004-01-15 |
| Summary: | summary |