The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink Universal Vial Adapter.
| Device ID | K924064 |
| 510k Number | K924064 |
| Device Name: | INTERLINK UNIVERSAL VIAL ADAPTER |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-12 |
| Decision Date | 1993-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412046414 | K924064 | 000 |
| 50085412004971 | K924064 | 000 |