The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Accucath Ace Intravascular Catheter.
| Device ID | K191232 |
| 510k Number | K191232 |
| Device Name: | AccuCath Ace Intravascular Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | C.R. Bard, Inc 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Mona Shahrebani |
| Correspondent | Mona Shahrebani C.R. Bard, Inc 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-09-18 |
| Summary: | summary |