The following data is part of a premarket notification filed by Carefusion, Inc. with the FDA for Maxzero Extension Sets With Needle-free Connector(s).
| Device ID | K193088 |
| 510k Number | K193088 |
| Device Name: | MaxZero Extension Sets With Needle-Free Connector(s) |
| Classification | Set, Administration, Intravascular |
| Applicant | Carefusion, Inc. 120 S State College Blvd, Suite 100 Brea, CA 92821 |
| Contact | Viviana Lai |
| Correspondent | Nesli Karakaya Carefusion, Inc. 120 S State College Blvd, Suite 100 Brea, CA 92821 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-06 |
| Decision Date | 2020-10-23 |