The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink(tm) Injection Site.
| Device ID | K925126 |
| 510k Number | K925126 |
| Device Name: | 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 | 1992-10-13 |
| Decision Date | 1993-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412014130 | K925126 | 000 |
| 50085412003950 | K925126 | 000 |
| 50085412003967 | K925126 | 000 |
| 50085412004872 | K925126 | 000 |
| 50085412004902 | K925126 | 000 |
| 50085412004919 | K925126 | 000 |
| 20085412004925 | K925126 | 000 |
| 50085412004933 | K925126 | 000 |
| 50085412004940 | K925126 | 000 |
| 50085412004988 | K925126 | 000 |
| 50085412002366 | K925126 | 000 |