The following data is part of a premarket notification filed by Bard Access Systems, Inc. (bard Has Joined Bd) with the FDA for Bd Centro Vena Acute Central Line (7 French Dual Lumen).
Device ID | K200266 |
510k Number | K200266 |
Device Name: | BD Centro Vena Acute Central Line (7 French Dual Lumen) |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | Bard Access Systems, Inc. (Bard Has Joined BD) 605 North 5600 West Salt Lake City, UT 84116 |
Contact | Breanna Casados |
Correspondent | Breanna Casados Bard Access Systems, Inc. (Bard Has Joined BD) 605 North 5600 West Salt Lake City, UT 84116 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-03 |
Decision Date | 2020-04-07 |