The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardport®, Slimport®, And X-port® Implanted Ports.
Device ID | K153359 |
510k Number | K153359 |
Device Name: | BardPort®, SlimPort®, And X-Port® Implanted Ports |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Contact | James R. Davis |
Correspondent | James R. Davis 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 | 2015-11-20 |
Decision Date | 2016-05-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BARDPORT 74447256 1994318 Live/Registered |
C. R. BARD, INC. 1993-10-06 |