The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Provena(tm) Midline Catheter.
Device ID | K213203 |
510k Number | K213203 |
Device Name: | Provena(TM) Midline Catheter |
Classification | Midline Catheter |
Applicant | C. R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Contact | Jeremy Kuyakana |
Correspondent | Jeremy Kuyakana 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 | 2021-09-29 |
Decision Date | 2022-05-13 |