The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Powermidline Catheter.
Device ID | K153393 |
510k Number | K153393 |
Device Name: | PowerMidline Catheter |
Classification | Midline Catheter |
Applicant | C.R. BARD, INC 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Contact | Casey Coombs |
Correspondent | Casey Coombs C.R. BARD, INC 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Product Code | PND |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-24 |
Decision Date | 2016-06-28 |
Summary: | summary |