The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Powerglide St Midline Catheter.
Device ID | K170158 |
510k Number | K170158 |
Device Name: | PowerGlide ST Midline Catheter |
Classification | Midline Catheter |
Applicant | C. R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Contact | Jacob Lee |
Correspondent | Jacob Lee 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 | 2017-01-18 |
Decision Date | 2017-06-01 |
Summary: | summary |