The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Needle*lock(tm) With Interlink(tm) Injection Site.
| Device ID | K914048 |
| 510k Number | K914048 |
| Device Name: | NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Marcia Marconi |
| Correspondent | Marcia Marconi BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1991-11-27 |