The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Extension Set With Bd Q-syte Luer Access Split Septum.
| Device ID | K142527 |
| 510k Number | K142527 |
| Device Name: | Extension Set With BD Q-Syte Luer Access Split Septum |
| Classification | Set, Administration, Intravascular |
| Applicant | ACACIA, INC. 785 CHALLENGER STREET Brea, CA 92821 |
| Contact | Dan Hyun |
| 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 | 2014-09-08 |
| Decision Date | 2014-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903851657 | K142527 | 000 |
| 50382903851640 | K142527 | 000 |
| 50382903851633 | K142527 | 000 |
| 50382903851626 | K142527 | 000 |
| 50382903851015 | K142527 | 000 |