The following data is part of a premarket notification filed by Bard Access Systems, Inc. (bard Has Joined Bd) with the FDA for Bd Acute Central Line.
| Device ID | K190855 |
| 510k Number | K190855 |
| Device Name: | BD Acute Central Line |
| 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 | Sean J. Loring |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-02 |
| Decision Date | 2019-11-01 |