The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerport Clearvue Slim Implantable Port.
Device ID | K122899 |
510k Number | K122899 |
Device Name: | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Contact | Amy Honey |
Correspondent | Amy Honey 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-21 |
Decision Date | 2012-11-15 |
Summary: | summary |