The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink System - T-connector Extension Set.
| Device ID | K921899 |
| 510k Number | K921899 |
| Device Name: | INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET |
| 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 | 1992-04-22 |
| Decision Date | 1993-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412004780 | K921899 | 000 |
| 50085412004759 | K921899 | 000 |
| 50085412004742 | K921899 | 000 |
| 50085412004667 | K921899 | 000 |
| 50085412004650 | K921899 | 000 |