The following data is part of a premarket notification filed by Carefusion 303 Inc. with the FDA for Maxzero Extension Sets With Needless Connector.
| Device ID | K171957 |
| 510k Number | K171957 |
| Device Name: | MaxZero Extension Sets With Needless Connector |
| Classification | Set, Administration, Intravascular |
| Applicant | Carefusion 303 Inc. 10020 Pacific Mesa Blvd San Diego, CA 92121 |
| Contact | Viviana Lai |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2017-07-19 |
| Summary: | summary |