The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for X-prot Duo Port.
Device ID | K032044 |
510k Number | K032044 |
Device Name: | X-PROT DUO PORT |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Contact | John C Knorpp |
Correspondent | John C Knorpp 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 | 2003-07-02 |
Decision Date | 2003-07-10 |
Summary: | summary |