The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powermidline Catheter.
Device ID | K162900 |
510k Number | K162900 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-17 |
Decision Date | 2016-12-14 |
Summary: | summary |